Job Description

General Summary:

The Senior Director, Quality GLP, Biomarkers and Research has overall accountability for strategic leadership and oversight of the end-to-end quality assurance strategy for proactive, risk-informed, and sustainable quality oversight and compliance with regulatory expectations across Vertex processes for clinical evidence generation and product vigilance

Key Duties and Responsibilities:
• Serves as a strategic partner to functional leaders across product modalities responsible for Research (including both non-regulated and GLP work), Biomarker Development, and Diagnostics in assuring appropriate quality/compliance oversight of processes and systems supporting effective delivery of these programs and the rigor and integrity of associated data.
• Defines strategy for and oversees tactical execution strategic plan by direct reports to provide effective oversight of research, assay development in support of pre-clinical and clinical research, GLP animal studies, in vitro diagnostic development, and all R&D vendors. Assures operational quality activities are informed by risk and assure the integrity of data submitted to regulatory authorities and in external forums.
• Responsible for assuring that key research & pre-clinical studies (internal and external) are performed in accordance with good scientific practices, good laboratory practices, Vertex policies and procedures and relevant local, regional, and international requirements.
• Leads an operational quality team responsible for identifying and anticipating potential compliance issues that may impact the ability to meet business goals, developing and implementing methods of improvement and resolution in a pragmatic and effective manner
• Oversees effective, timely, and appropriate identification, remediation, and escalation of quality issues in key Research, GLP, Biomarker, IVD and vendor governance-related activities across Vertex.
• Provides periodic updates on the overall health of Research, GLP, Biomarker, and IVD development-related processes and systems to functional leaders across Research, Biomarker Development, and Diagnostics.
• Oversees and assures timely and effective communication of summary trending and other insights on the quality of delivery in research, preclinical, biomarker, IVD work, and vendor performance to relevant business and quality leaders and in relevant forums.
• Oversees Inspection Readiness activities in collaboration with business and Quality Assurance partners related to research, GLP, biomarkers, IVD development activities.
• Chairs relevant operational governance meetings (e.g. QLT)
• Serves as the R&D Quality lead and oversees and guides staff participating in strategic cross-functional initiatives (e.g. Research Ethics, TRPM to improve quality, data integrity, and compliance to regulatory requirements and standards, ensuring a aligned Quality point-of-view is represented.
• Maintains an in-depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to Research, GLP, Biomarker, and IVD activities.
• Drives and oversees implementation of new and evolving regulatory requirements related to areas of responsibility.
• Leads and/or participates in industry forums and external initiatives related to areas of responsibility to influence policy development related to oversight of these activities, as aligned with functional leadership and Vertex interests.
• Provides strategic direction, oversight, coaching and mentoring to direct reports.

Education and Experience:

• M.S. (or equivalent degree) and 10 +years of relevant work experience, or
• B.S. in a scientific or allied health field (or equivalent degree) and 15+ years of relevant work experience, or relevant comparable background

Hybrid-Eligible Roles

In this Hybrid-Eligible role, you can choose to be designated as: 

Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility.

#LI-Hybrid #LI-AR1

Company Information

Who we are looking for

Looking for an experienced software test professional to work in the Boston office of our Global Markets IT Organization. Candidate must have 5+ years financial industry experience. Must possess familiarity with software test case repository systems such as qtest, task/bug tracking tools such as jira, and content collaboration software such as confluence. Must be able to analyze functional requirements and design specifications, design test strategies, create test plans, execute test cases, and validate the test results. Experience with automation tools such as UFT, Selenium, and Cucumber a plus.

This role can be performed in a hybrid model, where you can balance work from home and office to match your needs and role requirements.

Why this role is important to us

The team you will be joining is a part of State Street Global Markets (SSGM). When owners and managers of institutional assets need research, trading, securities lending and innovative portfolio strategies, they turn to SSGM business unit. As our investment research and trading arm, SSGM’s number one goal is to enhance and preserve our clients’ portfolio values by applying technology, optimizing trading, and linking asset classes and markets across the world.

Join us if making your mark in the capital markets industry from day one is a challenge you are up for.

What you will be responsible for

As Software QA Engineer AVP you will

• Ensure Functional Specifications contain appropriate details and they efficiently and effectively solve business needs.
• Provide detailed work estimates.
• Create Test case that link to requirements.
• Create new feature and regression test plans.
• Manage the execution of test plans utilizing offshore and onshore resources.
• Record QA status utilizing confluence QA Release Pages.
• Review development release process items are in accordance with audit and sdlc guidelines.

What we value

These skills will help you succeed in this role

• Must be comfortable working in a fast paced dynamic Agile environment.
• Experience managing large scale deliverables utilizing offshore resources.
• Must be able to multitask several projects of varying complexity.

Education & Preferred Qualifications

• 5+ Years experience in software qa preferable within financial domain.
• Familiar with AGILE development methodology
• Bachelors in Finance or Software IT required.

Are you the right candidate? Yes!

We truly believe in the power that comes from the diverse backgrounds and experiences our employees bring with them. Although each vacancy details what we are looking for, we don’t necessarily need you to fulfil all of them when applying. If you like change and innovation, seek to see the bigger picture, make data driven decisions and are a good team player, you could be a great fit.

About State Street

What we do. State Street is one of the largest custodian banks, asset managers and asset intelligence companies in the world. From technology to product innovation, we’re making our mark on the financial services industry. For more than two centuries, we’ve been helping our clients safeguard and steward the investments of millions of people. We provide investment servicing, data & analytics, investment research & trading and investment management to institutional clients.

Work, Live and Grow. We make all efforts to create a great work environment. Our benefits packages are competitive and comprehensive. Details vary by location, but you may expect generous medical care, insurance and savings plans, among other perks. You’ll have access to flexible Work Programs to help you match your needs. And our wealth of development programs and educational support will help you reach your full potential.

Inclusion, Diversity and Social Responsibility. We truly believe our employees’ diverse backgrounds, experiences and perspectives are a powerful contributor to creating an inclusive environment where everyone can thrive and reach their maximum potential while adding value to both our organization and our clients. We warmly welcome candidates of diverse origin, background, ability, age, sexual orientation, gender identity and personality. Another fundamental value at State Street is active engagement with our communities around the world, both as a partner and a leader. You will have tools to help balance your professional and personal life, paid volunteer days, matching gift programs and access to employee networks that help you stay connected to what matters to you.

State Street is an equal opportunity and affirmative action employer.

Salary Range:

$80,000 - $132,500 Annual

The range quoted above applies to the role in the primary location specified. If the candidate would ultimately work outside of the primary location above, the applicable range could differ.

Who we are

For more than 40 years, Covanta has been at the forefront of sustainable materials management, providing companies and communities world-class waste and resource solutions.

Through our diverse and scalable full-service capabilities, we’re leading the charge to a carbon-negative future—reducing, reusing, recycling and reimagining waste for the benefit of both people and planet.

Our differentiator comes from our vast ecosystem of technology, facilities, and partnerships, trusted by the world’s largest organizations to solve their most pressing environmental challenges, and achieve their most ambitious environmental, social, and governance (ESG) goals​.

All that we’re missing is you.  Join us today!!

Our values

Diversity, inclusivity, engagement—these are the values that help us foster a strong sense of community within Covanta. By embracing the unique talents, perspectives, and experiences of our employees, we cultivate an environment that embraces teamwork, encourages open dialogue, and provides opportunities for growth.

About the role

SIGN-ON BONUS: $2,500 (1/2 after 30 days, 1/2 after 90 days)

As a Control Room Operator, you will execute the approved plant start-up and shutdown procedures to assure that the facility meets it's operational, environmental, and safety commitments while operating in a safe and environmentally efficient manner.

Position Responsibilities:

• Provide guidance to Crane, Auxiliary, and Back Plant Operators to maintain a safe and efficient operation

• Effectively monitor Covanta operations systems and have strong working knowledge of boiler, turbine, and auxiliary equipment operations

• Experienced in reading blueprints, P&ID’s, and schematic specifications

• Manage critical events and prioritize tasks for completion at times during emergency, providing clear directions in operational, safety and environmental tasks

• Respond to operational alarms, taking immediate corrective action

• Demonstrate solid understanding of operational best practices, including the ability to problem solve and make sound decisions that supports Covanta’s safety and operational goals

Position Requirements & Qualifications:

• High School Diploma or equivalent

• Requires MA 2nd Engineers license

• Successful completion of ASME QRO Provisional Licensing exam required within the first year of holding the position

• Must be able to work 12 hour rotating shifts.

Total Rewards & Compensation:

• Competitive Base Salary

• Day one employee benefits: competitive health insurance options, PTO, retirement savings plan and 401K match

Physical Demands of the Role:

• Ability to walk, stand, sit, and climb

• Ability to lift/carry 50lbs

• Ability to work from heights and in confined spaces

• Qualify to wear a full-face respirator 

• Consistently work in various weather conditions

#LI-RR1

Our DEI commitment

Covanta is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.

EOE AA M/F/Protected Veteran Status/Disability EEO is the Law Poster (The poster can be found at https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf). Level, Title and/or Salary may be adjusted based on the applicant's experience or skills.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to access job openings or apply for a job on this site as a result of your disability. You can request reasonable accommodations by contacting us at careers@covanta.com.

Administer the Lineage Safety Program to ensure a safe, controlled, and risk-free environment while following all regulatory and company safety standards, policies, and procedures. Promote a safety culture with the goal of achieving an incident-free work environment.

KEY DUTIES AND RESPONSIBILITIES

• Work with leadership on processes and procedures to prepare for internal and external audits
• Partner with Operations to help resolve facility and customer issues
• Conduct accident investigations and take steps to ensure safety policies are understood and followed by all parties
• Lead meetings to inform team members of new or changing safety policies and procedures, and address safety and/or quality issues
• Monitor warehouse safety supplies and notify operations of replacement needs
• Maintain accurate and up-to-date recordkeeping systems including logs, binders, and other records

ADDITIONAL DUTIES AND RESPONSIBILITIES

• Attend training sessions and other events requested by Operations
• May conduct new-hire safety orientations

MINIMUM REQUIREMENTS (KNOWLEDGE, SKILLS, ABILITIES)

• High School diploma or GED
• 2 years’ related experience in safety compliance roles
• Knowledge of country’s safety regulations/standards, governing bodies, and employer obligations for work-related injuries
• Proficient computer skills including Microsoft Office Suite
• Excellent verbal and written communication skills
• Ability to work in temperatures as low as -20 Fahrenheit in cold storage sites or up to 100 degrees Fahrenheit in dry storage sites while wearing company provided personal protective equipment and freezer gear  
• Must be comfortable with various noise levels, at times, can be loud

Why Lineage?

This is an excellent position to begin your career path within Lineage! Success in this role enables greater responsibilities and promotions! A career at Lineage starts with learning about our business and how each team member plays a part each and every day to satisfy our customers’ requirements. Beyond that, you’ll help us grow and learn on our journey to be the very best employer in our industry. We’ll ask you for your opinion and ensure we do our part to keep you developing and engaged as we grow our business. Working at Lineage is energizing and enjoyable. We value respect and care about our team members.

Lineage is an Equal Employment Opportunity Employer and is committed to compliance with all federal, state, and local laws that prohibit workplace discrimination and unlawful harassment and retaliation.  Lineage will not discriminate against any applicant on the basis of race, color, age, national origin, religion, physical or mental disability or any other protected status under federal, state and local law.

Benefits

Lineage provides safe, stable, reliable work environments, medical, dental, and basic life and disability insurance benefits, 401k retirement plan, paid time off, annual bonus eligibility, and a minimum of 7 holidays throughout the calendar year.

Who we are looking for

We are seeking to recruit an enthusiastic Compliance professional, to join our Corporate Compliance team. The position is for a self-motivated Compliance Officer with technical aptitude providing regulatory and financial crime compliance oversight as part of the Global Compliance team. The candidate will play a fundamental role in handling a wide variety of compliance-related matters. Responsibilities will include working closely with Management in designing and implementing compliance control processes and procedures, executing compliance risk assessments, and reporting compliance health to the appropriate business unit and/or legal entity governing bodies.   

This role will be performed on site.

Why this role is important to us

The team you will be joining plays an important role in the overall success of the organization. Across the globe, institutional investors rely on us to help them manage risk, respond to challenges, and drive performance and profitability. To make that happen we need teams like yours to help navigate employees and the organization as a whole. In your role you will strive for cutting-edge solutions, that are straightforward and scalable. You will help us build resilience and execute day to day deliverables at our best. Join us if making your mark in the financial services industry from day one is a challenge you are up for.

What you will be responsible for

As a Compliance Officer, VP you will:

• Execute the compliance framework to ensure State Street meets its legal and regulatory obligations including program health assessments, internal controls testing, and governance reporting

• Escalate regulatory issues and monitor product launches and/or changes in business models for assigned areas to ensure that compliance programs reflect such developments and the accompanying legal requirements

• Provide guidance to risk owners on the substance of regulatory obligations in order for them to understand the obligations and standards expected by regulators to build scalable controls to mitigate and monitor risk

• Proactively engage with business management to develop corrective action plans to effectively manage change and improve processes and procedures, as necessary, to mitigate risk exposure

• Foster a positive culture of compliance by working proactively with the Business, Operations, Risk and Controls functions, and other Compliance professionals to ensure that best practices and systems are in place to facilitate State Street business growth and the overall success in accordance with applicable laws, rules, regulations and internal policy

• Provide project management support on compliance-related projects and initiatives, as requested, to ensure success in alignment with agreed timelines and goals

What we value

These skills will help you succeed in this role

• Ability to quickly analyze regulations, particularly those relation to financial services

• Strong attention to detail, ability to see through tasks until completion

• Proactive attitude, with strong communication skills

• Ability to meet challenging deadlines in a dynamic environment

• Willingness to participate in global and regional projects

• Co-operative attitude, ability to work with colleagues globally

• Proficiency in Excel, Word, PowerPoint

• An effective and relatable “culture of compliance” mentality

Education & Preferred Qualifications

• Bachelor’s Degree

• Relevant work experience in Compliance, Legal, Audit or Risk Management

• Working knowledge of Excel, PowerPoint and other Microsoft Office applications

What we offer

Wide range of benefits, including:

• Medical

• Prescription Drug

• Health Savings Account (HSA)

• Flexible Spending Accounts (FSAs)

• Dental

• Vision

• Employee-Paid Life and Accidental Death & Dismemberment (AD&D) Insurance

• Employee-Paid Long-Term Disability

• Critical Illness Insurance

• Accident Insurance & Hospital Indemnity Insurance

• Business Travel Accident Insurance

• Short-Term Disability

• Identity Theft Protection

• Legal Benefits

• BeWell Programme

• Paid Time Off

• Employee Assistance Program (EAP)

• Salary Savings Program (SSP)

Are you the right candidate? Yes!

We truly believe in the power that comes from the diverse backgrounds and experiences our employees bring with them. Although each vacancy details what we are looking for, we don’t necessarily need you to fulfil all of them when applying. If you like change and innovation, seek to see the bigger picture, make data driven decisions and are a good team player, you could be a great fit.

About State Street

What we do. State Street is one of the largest custodian banks, asset managers and asset intelligence companies in the world. From technology to product innovation, we’re making our mark on the financial services industry. For more than two centuries, we’ve been helping our clients safeguard and steward the investments of millions of people. We provide investment servicing, data & analytics, investment research & trading and investment management to institutional clients.

Work, Live and Grow. We make all efforts to create a great work environment. Our benefits packages are competitive and comprehensive. Details vary by location, but you may expect generous medical care, insurance and savings plans, among other perks. You’ll have access to flexible Work Programs to help you match your needs. And our wealth of development programs and educational support will help you reach your full potential.

Inclusion, Diversity and Social Responsibility. We truly believe our employees’ diverse backgrounds, experiences and perspectives are a powerful contributor to creating an inclusive environment where everyone can thrive and reach their maximum potential while adding value to both our organization and our clients. We warmly welcome candidates of diverse origin, background, ability, age, sexual orientation, gender identity and personality. Another fundamental value at State Street is active engagement with our communities around the world, both as a partner and a leader. You will have tools to help balance your professional and personal life, paid volunteer days, matching gift programs and access to employee networks that help you stay connected to what matters to you.

State Street is an equal opportunity and affirmative action employer.

Discover more at StateStreet.com/careers

Salary Range:

$100 000 - $167 500 Annual

The range quoted above applies to the role in the primary location specified. If the candidate would ultimately work outside of the primary location above, the applicable range could differ.

Job Description

General Summary:

The Associate Director, GMP Operational Quality is responsible for oversight of team activities, development of personnel and ensuring quality of deliverables within department purview. The incumbent has comprehensive knowledge of principles and application of quality assurance and compliance. The incumbent is responsible for development of group goals and projects ensuring alignment with corporate goals and compliance with all regulatory requirements, refining goals and projects when necessary. The incumbent not only coordinates group responsibilities to ensure timely delivery to support business, but mentors team members to provide individual development in addition to efficient and valuable service to project teams.

**In this a 2nd, shift, On-Site designated role. ou will work five days per week on-site with ad hoc flexibility.**

Key Duties and Responsibilities:

• Lead a Quality team: primarily responsible for providing quality oversight and support to business activities within purview at Vertex
• Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions
• Enable team to achieve team goals/objectives and enable their individual career development
• Develop and maintain compliant quality processes to support GMP activities
• Oversee the QA support of Change Controls, GMP investigations (deviations) and associated CAPAs.
• Track performance metrics and report to Sr Management; develops tactics to improve performance outcomes
• Participate in inspection readiness activities and lead Quality development discussions as necessary during regulatory site inspections.
• Support review of regulatory submissions, as applicable
• Lead continuous improvements of department processes, realizing efficiency gains, and ensuring team continues to meet expanding business needs with lean resources.
• Lead and follow up on any QLT action items assigned.
• Identify and communicate risks and assist with risk mitigation plans as necessary
• Supports internal audit or external audit programs; assists in preparation of audit responses
• Provide comprehensive knowledge support for partner and regulatory agency audits
• Assist management team in budgeting and scheduling
• Responsible for the following activities related to people management responsibilities:
• Talent Acquisition/ Recruiting/Interviewing/ Selection/Onboarding
• Performance Management (goals, monitoring, reviews);
• Monitoring /Supporting Employee Engagement and Retention;
• Succession Planning;
• Accomplishing staff results by communicating job expectations, planning, coaching, training and developing personal growth opportunities through IDPs.
• Accountable to provide oversight of day to day team operations
• Assists with workforce planning/resource modeling and to update through forecasting activities

Knowledge and Skills:

• In-depth and specialized knowledge of both the conceptual and practical application of cGMPs in a biotech setting; in-depth knowledge of global GMP requirements and managing quality in support GMP manufacturing
• Demonstrated success in building high-performing teams and skilled at managing team and individual development
• Strong management skills with the ability to lead and motivate a team in a fast-paced environment while maintaining a high degree of quality, accuracy and timeliness
• Substantial background in managing complex projects/teams within stated objectives and timelines and with a strong understanding of the underlying business drivers; skilled at applying project management processes / tools to lead meetings, assist with project planning, and facilitate attainment of project objectives
• Ability to independently lead cross-functional teams and represent the interests, strategies and objectives of Quality unit
• Strong skills in mentoring staff and transferring technical knowledge to enable their capabilities and development
• Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex concepts with the ability to influence leaders, customers, or vendors to adopt of a new point of view and/or to take action
• Demonstrated ability to evaluate complex quality matters and make decisions utilizing risk-based approach; identifies and leverages the appropriate expertise to implement solutions
• Substantial experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
• Extensive exposure with multiple regulatory agencies across applicable GxPs during inspections
• Experience with electronic document management systems desirable (e.g., Trackwise, Veeva)

Education and Experience:

• Bachelor's degree in a scientific or a allied health or equivalent degree
• Typically requires 8 years of work experience and 4 years of management experience, or the equivalent combination of education and experience

On-Site Roles

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

#LI-Onsite #LI-AR1

Company Information

At HCSC, we consider our employees the cornerstone of our business and the foundation to our success. We enable employees to craft their career with curated development plans that set their learning path to a rewarding and fulfilling career.

Come join us and be part of a purpose driven company who is  invested in your future!

Job Summary

***TELECOMMUTE: This position will work from home 5 days a week. Eligible for the state of Oklahoma ONLY. Candidate will have to pass a WFH speed test.***

*Out of state applications will not be considered.*

This position is responsible for facilitating clinical quality improvement projects and evaluation of Provider/Provider Group compliance with clinical practice guidelines. This role will consult with Medical Groups, physicians, providers, and other resources to assess, plan, facilitate implement, coordinate, monitor and evaluate options and services required to meet clinical quality improvement project objectives.

JOB REQUIREMENTS:

• Registered Nurse (RN), LPN, LVN, Physician's Assistant OR MSW (Master of Social Work)/LCSW (Licensed Clinical Social Worker) or other BH licensure with current, unrestricted license to practice in the state of operations OR Respiratory Therapist with master’s level or above degree
• Medical specialty certification (Certified Professional in Healthcare Quality (CPHQ) or Diabetic Education) OR Bachelor Degree in medical field such as Nursing, Health Care Administration.
• 3 years clinical practice experience.
• 2 years' experience in health insurance or managed care.
• 2 years quality improvement and/or project management experience.
• Experience conducting presentations for member and/or provider training.
• Current unrestricted  driver’s license.
• Ability to travel including overnight stays.
• Verbal and written communications skills.
• Data analysis experience.
• PC proficiency to include Word, Excel, and PowerPoint.

PREFERRED EXPERIENCE:

• Licenses Nurse with HEDIS experience HIGHLY PREFERRED
• Health plan QI (qualify improvement) HIGHLY PREFERRED
• HEDIS audit experience.
• Familiarity with EMR (electronic medical record) and Inovalon (HEDIS software)

We encourage people of all backgrounds and experiences to apply.

Even if you don’t think you are a perfect fit, apply anyway - you might have qualifications we haven’t even thought of yet.

*Sponsorship will not be provided for this role.*

Are you being referred to one of our roles? If so, ask your connection at HCSC about our Employee Referral process!

HCSC Employment Statement:

HCSC is committed to diversity in the workplace and to providing equal opportunity and affirmative action to employees and applicants. We are an Equal Opportunity Employment / Affirmative Action employer dedicated to workforce diversity and a drug-free and smoke-free workplace. Drug screening and background investigation are required, as allowed by law. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Who we are looking for

Institutional Broker/Dealer is seeking an experienced compliance professional. The role must maintain and apply current knowledge of FINRA, NYSE, SEC, NFA and MSRB rules and regulations. The position is responsible for supporting the business teams in the implementation of all required policies and assist the Chief Compliance Officer with the compliance oversight of the Broker/Dealer’s trading activities. This includes addressing trading practice and applicable reporting requirements, including CAT, TRACE and MSRB. The candidate should have experience with: Domestic and International Institutional and Accounts DVP/RVP, Equities and Fixed Income, Trading Practice Compliance, Trade Reporting: CAT, TRACE, communicating with regulators, monitoring and surveillance of controls, as well as strong knowledge of securities rules and regulations covering operating procedures.

Job can be performed in Boston or New York. Work pattern is 4 days in the office and 1 day remote.

Why this role is important to us

The team you will be joining plays an important role in the overall success of the organization. Across the globe, institutional investors rely on us to help them manage risk, respond to challenges, and drive performance and profitability. To make that happen we need teams like yours to help navigate employees and the organization as a whole. In your role you will strive for cutting-edge solutions, that are straightforward and scalable. You will help us build resilience and execute day to day deliverables at our best. Join us if making your mark in the financial services industry from day one is a challenge you are up for.

What you will be responsible for

As Trading Compliance Manager you will

• Coordinate with various internal and external constituents to ensure accurate trade and execution reporting to the SEC, FINRA and various SRO’s regarding applicable trade reporting requirements including TRACE, MSRB, and CAT

• Implement and enhance the Compliance Oversight Program in alignment with division methodology addressing all relevant risks and corporate and local requirements

• Proactively engage with First Line of Defense, control functions (Risk, Legal, Audit and IT) and participate in and provide management oversight on the development of the Compliance Oversight Program in response to changes in regulatory obligations and industry standards and best practices

• Provide advice to firm’s Registered Representatives regarding applicable securities rules, regulations and firm policies

• Assist in development and implementation of Compliance Oversight Program and applicable surveillance/monitoring programs to review the firm's activities to remain in compliance with all aspects of regulatory standards

• Demonstrate excellent communication skills, both oral and written. Should have the ability and experience to draft clear and professional correspondence, policies and procedures and other documents of both legal and business nature. Must be able to correspond with all regulators and auditors

• Work with Chief Compliance Officer to ensure appropriate support as needed for any regulatory matters revolving around the firm's activities by compiling data and drafting responses

What we value

These skills will help you succeed in this role

• Have an in-depth understanding of evaluating risk and compliance initiatives and determining regulatory compliance risks at a global financial institution

• Analytical/detail-oriented mindset and a good sense of judgment

• Self-motivated and able to prioritize workflow and work independently

Education & Preferred Qualifications

• Bachelors Degree or Higher Required.

• Series 7 and 24 qualifications required (or the ability to retain within 6 months of hire)

• Minimum of 7 years’ experience in securities compliance, legal or operations

• Strong knowledge of FINRA, SEC and State Securities rules and regulations including CAT, TRACE, MSRB, and Electronic Blue Sheets

• Knowledge of rules and regulations pertaining to banks or bank holding companies participating in capital markets

• Knowledge of CFTC and NFA rules are a plus

What we offer

Wide range of benefits, including:

• Medical

• Prescription Drug

• Health Savings Account (HSA)

• Flexible Spending Accounts (FSAs)

• Dental

• Vision

• Employee-Paid Life and Accidental Death & Dismemberment (AD&D) Insurance

• Employee-Paid Long-Term Disability

• Critical Illness Insurance

• Accident Insurance & Hospital Indemnity Insurance

• Business Travel Accident Insurance

• Short-Term Disability

• Identity Theft Protection

• Legal Benefits

• BeWell Programme

• Paid Time Off

• Employee Assistance Program (EAP)

• Salary Savings Program (SSP)

Are you the right candidate? Yes!

We truly believe in the power that comes from the diverse backgrounds and experiences our employees bring with them. Although each vacancy details what we are looking for, we don’t necessarily need you to fulfil all of them when applying. If you like change and innovation, seek to see the bigger picture, make data driven decisions and are a good team player, you could be a great fit.

About State Street

What we do. State Street is one of the largest custodian banks, asset managers and asset intelligence companies in the world. From technology to product innovation, we’re making our mark on the financial services industry. For more than two centuries, we’ve been helping our clients safeguard and steward the investments of millions of people. We provide investment servicing, data & analytics, investment research & trading and investment management to institutional clients.

Work, Live and Grow. We make all efforts to create a great work environment. Our benefits packages are competitive and comprehensive. Details vary by location, but you may expect generous medical care, insurance and savings plans, among other perks. You’ll have access to flexible Work Programs to help you match your needs. And our wealth of development programs and educational support will help you reach your full potential.

Inclusion, Diversity and Social Responsibility. We truly believe our employees’ diverse backgrounds, experiences and perspectives are a powerful contributor to creating an inclusive environment where everyone can thrive and reach their maximum potential while adding value to both our organization and our clients. We warmly welcome candidates of diverse origin, background, ability, age, sexual orientation, gender identity and personality. Another fundamental value at State Street is active engagement with our communities around the world, both as a partner and a leader. You will have tools to help balance your professional and personal life, paid volunteer days, matching gift programs and access to employee networks that help you stay connected to what matters to you.

State Street is an equal opportunity and affirmative action employer.

Discover more at StateStreet.com/careers

Salary Range:

$110 000 - $185 000 Annual

The range quoted above applies to the role in the primary location specified. If the candidate would ultimately work outside of the primary location above, the applicable range could differ.

Field Service Satellite Control Network Site Support Integrator

Job Category: Engineering and Technical Support

Time Type: Full time

Minimum Clearance Required to Start: Secret

Employee Type: Regular

Percentage of Travel Required: Up to 10%

Type of Travel: Continental US

* * *

What You’ll Get to Do

CACI, Inc. is accepting applications for a Field Service Satellite Control Network Site Support Integrator (SSI) supporting the US Space Force Satellite Control Network (SCN) at New Boston AFS Tracking Station (NHS) and Cape Canaveral AFS, FL, Eastern Vehicle Checkout Facility (EVCF).
 

The SSI will be the depot-level liaison at the SCN location to interface, coordinate, monitor, problem solve, analyze and oversee depot-level work such as site modifications and development efforts).
 

More About the Role

The Site Support Integrator (SSI) will interface with site personnel and commander ensuring communication of upcoming efforts are approved ahead of any Government and Contractor travel or work. The SSI performs escort duties as requested by the Government and shall be responsible for coordinating Visitor Access Requests (VAR) and escort authorization. Will also provide site support to review TOs and drawings.  The SSI maintains and ensures accuracy of baseline site mission floor plan data and provides to stakeholders, upon request. The SSI also reviews schedules for implementation of engineering analysis, requirements affecting a specific system and coordinating scheduling requirements with the using command. Coordinate, monitor and assess the activities of all baseline equipment and software. Provides coordination with the user representatives at the operating locations. The CSSI also minimizes conflict with operations and provides technical assistance, ensures these activities are IAW approved installation criteria, plans and schedules that conform to the approved design. This SSI will also participate in hardware and software installations, tests, and acceptance activities.

You’ll Bring These Qualifications

• Viable candidates must hold, at minimum, a BA/BS degree or equivalent experience

• A minimum of 5 years' related work experience

• Must be a US Citizen and able to attain DoD Secret Security Clearance

• Solid understanding of operational technical manuals, drawings, and schematics required

• Experience with software and hardware testing and evaluation

• Proficient with Microsoft Office Tool Suite

What We Can Offer You:

• We’ve been named a Best Place to Work by the Washington Post.

• Our employees value the flexibility at CACI that allows them to balance quality work and their personal lives.

• We offer competitive benefits and learning and development opportunities.

• We are mission-oriented and ever vigilant in aligning our solutions with the nation’s highest priorities.

• For over 55 years, the principles of CACI’s unique, character-based culture have been the driving force behind our success.

Company Overview:

CACI is an Equal Opportunity/Affirmative Action Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other protected characteristic.

Pay Range: There are a host of factors that can influence final salary including, but not limited to, geographic location, Federal Government contract labor categories and contract wage rates, relevant prior work experience, specific skills and competencies, education, and certifications. Our employees value the flexibility at CACI that allows them to balance quality work and their personal lives. We offer competitive compensation, benefits and learning and development opportunities. Our broad and competitive mix of benefits options is designed to support and protect employees and their families. At CACI, you will receive comprehensive benefits such as; healthcare, wellness, financial, retirement, family support, continuing education, and time off benefits. Learn more here

The proposed salary range for this position is:

$58,800 - $123,400

Job Description

General Summary:

The Senior Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Senior Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product manufacturing and disposition.

**In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.**

KEY DUTIES AND RESPONSABILITIES:

• Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems.
• Responsible for approval of COAs, generating BSE/TSE statement and product labelling.
• Responsible for archival of batch records and other supporting documents in electronic Document Management System (eDMS).
• Provide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including shipment.
• Review and approval of Manufacturing documents.
• Responsible for raw material release, area clearance, line clearance and equipment release.
• May be required to assist with activities associated with equipment, instrument, utilities, and/or facility qualification activities including change control, and support of site programs.
• Provide QA support of change controls, GMP investigations and CAPAs.
• Participate in compliance walkthroughs and help drive the closure of any audit observations.
• Responsible for identifying risks and communicating gaps for GMP process/systems.
• Responsible for identifying risks and communicating any gaps for quality processes optimization for area/equipment release, material disposition, quality systems etc.
• Participate in continuous improvements of department processes.
• Participate in inspection readiness and support activities.  
• Participate in process improvement initiatives and ongoing Project (as necessary).
• Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issue in a timely manner.

REQUIRED EDUCATION AND EXPERIENCE:

• Demonstrated success by independently leading cross-functional teams
• Experience providing QA support and oversight of GMP manufacturing operation including equipment/ facilities qualification, utilities and batch release.
• Experience successfully leading event investigations, Root Cause Analysis and CAPA Experience with network based applications such as Oracle, Veeva
• Master’s degree with 2-3 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field with minimum 5 years of relevant work experience, or relevant comparable background.            

On-Site Roles

In this 2nd shift, On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

#LI-Onsite #LI-AR1

Company Information

SSGA is seeking a dynamic and experienced individual to support the firm’s ESG compliance program. The successful candidate will be a key member of the Compliance organization and will be located in Boston, MA. They will report directly to the Head of ESG Compliance.

The candidate will play a key role in the global ESG compliance program, supporting ESG strategic initiatives related to marketing, products, client reporting and asset stewardship.

What you will be responsible for

As the ESG Compliance, Assistant Vice President, this role will work directly on the following responsibilities:

• Develop and maintain a general understanding of requirements for corporate sustainability practice and regulatory considerations for fiduciaries that exercise investment discretion in ESG investment strategies and products; act as subject matter expert on ESG regulation for compliance team
• Develop strong relationships with global business teams on ESG matters and proactively engage to provide solutions and guidance on ESG regulatory requirements
• Play a key role in the implementation and enhancement of Marketing Compliance reviews of ESG related material to support strategic initiatives and facilitate business growth
• Participate in the ongoing implementation and execution of risk assessments and other testing related to ESG
• Develop global guidance on ESG regulatory requirements

Education & Preferred Qualifications

• Bachelor’s degree and a minimum of 4-5 years relevant experience, preferably in the financial industry or asset management industry.
• Additional professional, academic or relevant industry qualifications are desirable
• Proven superior communication skills - both verbal and written
• Strong analytical thinking, problem solving, research, time management, and verbal and written communication skills, including an ability to actively communicate concerns
• Collaborative by nature with the capability to help others achieve more
• Ability to form and cultivate positive relationships with internal partners
• Previous ESG experience, particularly within compliance, is highly desirable

Are you the right candidate? Yes!

We truly believe in the power that comes from the diverse backgrounds and experiences our employees bring with them. Although each vacancy details what we are looking for, we don’t necessarily need you to fulfil all of them when applying. If you like change and innovation, seek to see the bigger picture, make data driven decisions and are a good team player, you could be a great fit.

About State Street

What we do. State Street is one of the largest custodian banks, asset managers and asset intelligence companies in the world. From technology to product innovation, we’re making our mark on the financial services industry. For more than two centuries, we’ve been helping our clients safeguard and steward the investments of millions of people. We provide investment servicing, data & analytics, investment research & trading and investment management to institutional clients.

Work, Live and Grow. We make all efforts to create a great work environment. Our benefits packages are competitive and comprehensive. Details vary by location, but you may expect generous medical care, insurance and savings plans, among other perks. You’ll have access to flexible Work Programs to help you match your needs. And our wealth of development programs and educational support will help you reach your full potential.

Salary Range:

$80.000 - $132.500 Annual

The range quoted above applies to the role in the primary location specified. If the candidate would ultimately work outside of the primary location above, the applicable range could differ.

Job Description

Director of Quality Cell.& Gene, Manufacturing Systems is accountable for ensuring Operational Systems  related improvements and projects are planned, prioritized, and executed in a systematic manner. The role is accountable for leading/supporting continuous improvements of quality operations processes, development of digital roadmaps including Quality user requirements, details of Quality process flows and assuring realization of such requirements into systems and procedures. 

The role provides Quality oversight to assure that the Quality requirements are appropriately built in and executed within the key Vertex initiatives such as commercial launches, technology projects and efficiency driving measures.

The role will be highly cross-functional and will require meticulous planning, resources allocation and effective partnering with quality and other stakeholders – MSAT, DTE, QC – to participate in Cell and Gene therapies program oversight and associated governance.

Key Duties & Responsibilities

• Lead the development and implementation of continuous improvement quality operations activities and  processes.
• Ensure Quality Operations processes are in compliance with regulations. Proactively identify gaps and mitigate risks.
• Lead/Participate in development the strategy for project and represent as the  quality expert in governance forums to ensure Quality requirements are appropriately included and prioritized for implementation.
• Proactively recognize and work with others to resolve risks to the timeliness or quality of the deliverables, escalating appropriately.
• Establish / evolve project team, identify opportunities for efficiencies, and demonstrate agility negotiating and shifting priorities, course correct where needed to ensure successful outcomes.
• Develop effective organization structure to efficiently support ongoing Quality Operations continuous improvements/projects and other operational activities, build out dashboards to report progress and at-risk areas.
• Anticipate Quality and regulatory needs and adjust QA input to efficiently and effectively drive / support deliverables.
• Leverage technical expertise and experiences across QA to resolve critical challenges; ensure effective communication and escalation where needed.
• Align resources and priorities across Quality functions to successfully lead / partner on effective change management efforts , and oversee development of cut-over plans where needed.
• Champion changes, establish/influence a change-agile work environment and lead the team effectively.

Knowledge and Skills:

• Broad technical experience in Cell and Gene Therapy technology clinical to commercial life cycle management, and manufacture science and technology.
•  In depth knowledge of EU and FDA regulations covering Cell & Gene GMP/GDP manufacturing operations and distribution.
• Effective business analytical skills to allow for critical analysis of the processes and practices.
• Ability to chair governance meetings, and establish dashboards, reporting.
• Solid project management skills, ability to work on advanced reporting industry standard solutions such as Smartsheet, PowerBI.
• Experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.
• Excellent communication skills; proven track record
• Influencing/building/promoting a culture of Quality Excellence
• Strong leadership, ability to work in a matrix environment and an innate ability to collaborate and build relationships

Education and Experience:

• Bachelor's degree in an engineering/Lifesciences field and/ or Master’s degree in business analytics/management/industrial engineering.
• Typically requires 10+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment.
• A minimum of 5 years leadership experience leading teams or matrix management of projects.

Company Information

Job Description

POSITION SUMMARY:

The Associate Director, Information Systems Management entails providing risk based oversight to Computerized Systems Life Cycle activities across broad spectrum of technologies ranging from Automated Systems to Enterprise Wide systems and Software-as-a-Service (SaaS) solutions. This role ensures risk-based, overall integrity of electronic data across all stages of data life cycle and leads development and refinement of quality management systems standards and policies to align with various GxP regulations.

RESPONSIBILITIES:

The responsibilities of this position will include, but are not limited to, the following:

• Advance deeper understanding of GxP regulations (GxP predicate rules) to ensure appropriate phase-appropriate systems life cycle management and oversight.
• Define and adopt emerging techniques of software testing and deployment based on standard industry practices and general guidance.
• Collaborate with Business and Quality Leaders to develop and implement data integrity metrics to ensure effective QMS performance management.
• Leverage varied and specialized QA technical experience develop and implement effective data integrity governance / controls that improve the impact of the Quality function.
• Participate in leadership forums such as Quality Leadership Teams to ensure consistent implementation and interpretation of data integrity governance controls.
• Carry out appropriate analysis based on the risk/issue and take action to mitigate potential risks and deficiencies when making decisions.
• Participate in/ lead inspection readiness efforts and represent as a subject matter expert during inspections and internal audits events.
• Align resources and strategies across management structures to successfully lead broad change efforts and ensure meaningful change adoption across areas or functions.

Key Technical Knowledge, Skills and Competencies:

• Specialized depth of knowledge and demonstrated experience with global regulatory requirements and standards/best practices for computer systems within GxP-regulated environments
• Demonstrated depth and breadth of global health regulatory agency knowledge and GxP experience with current knowledge of industry trends and best practices for computer systems quality, data integrity, compliance and systems controls effectiveness
• Broad and deep quality management, computer systems management, process management, project management and continuous improvement knowledge and experience
• Influencing/building/promoting a culture of Quality and Excellence
• Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions
• Skilled at applying risk management principles and processes, managing change
• Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers.
• Must be able to organize and prioritize work effectively to meet timelines with quality deliverables.
• Must be able to work independently and in a collaborative team setting.
• Specialized depth of knowledge of health agencies' GxP governing regulations
• Hands on, extensive experience in implementing electronic records and signatures governing regulations such as FDA's 21 CFR Part11.
• Familiarity with medical device regulations to appropriately assess and validate embedded med device software applications.
• Preferred industry standard audit certification.
• Preferred industry accredited certification of process improvement methodologies such as Six Sigma, Lean Sigma.

Education and Experience:

• Bachelor's Degree in a scientific or allied health field
• 8 years of experience or the equivalent combination of education and experience, inclusive of 2 years of supervisory experience leading cross functional teams for large enterprise wide initiatives

Hybrid-Eligible Roles

In this Hybrid-Eligible role, you can choose to be designated as: 

Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility.

#LI-Hybrid #LI-AR1

Company Information

CLA is a top 10 national professional services firm where our purpose is to create opportunities every day, for our clients, our people, and our communities through industry-focused wealth advisory, digital, audit, tax, consulting, and outsourcing services. Even with more than 8,500 people, 130 U.S. locations, and a global reach, we promise to know you and help you.

CLA is dedicated to building a culture that invites different beliefs and perspectives to the table, so we can truly know and help our clients, communities, and each other.

Our Perks:

• Flexible PTO (designed to offer flexible time away for you!)

• Up to 12 weeks paid parental leave

• Paid Volunteer Time Off

• Mental health coverage

• Quarterly Wellness stipend

• Fertility benefits

• Complete list of benefits here

CliftonLarsonAllen, LLP is hiring an Assurance Director or Manager to support our Nonprofit practice, in Massachusetts. Office locations include: Boston, Quincy, Lexington, Andover, and Worcester.

How you’ll create opportunities in this Assurance Manager or Director role:

• Manage and develop relationships with great clients.

• Assist clients in obtaining necessary funding to continue to positively impact their community.

• Assist clients with meeting their audit and financial planning objectives by using a range of tools.

• Be creative with staff development, mentoring, and overseeing client engagement teams.

• Lead the engagement progress by monitoring time budgets and deadlines for adherence.

• Communicate important developments to the engagement principal along with facts, conclusions, and recommendations.

What you will need:

• You have a Bachelor's Degree in Accounting, Finance, or a related field.

• You have a minimum of 6 years of public accounting experience with emphasis in financial statement preparation and audits.

• CPA license certification is required.

• You jump at the chance to help others and you’re ready to lead a team of high-performing people.

• You have a knack for solving issues and can confidently bring solutions to the table.

• You love to work with clients’ to help their businesses succeed strategically.

#LI-BV1

Equal Opportunity Employer /AA Employer/Minorities/Women/Protected Veterans/Individuals with Disabilities.
 
Click here to learn about your hiring rights.

Wellness at CLA

To support our CLA family members, we focus on their physical, financial, social, and emotional well-being and offer comprehensive benefit options that include health, dental, vision, 401k and much more.

To view a complete list of benefits click here.

Salary Range:

$90,000 - $142,500 Annual

The range quoted above applies to the role in the primary location specified. If the candidate would ultimately work outside of the primary location above, the applicable range could differ.