Top 206 Senior quality assurance Jobs in Boston Ma

Senior Manager, Clinical Study Quality Lead (Hybrid)
Vertex Pharmaceuticals —Boston, MA
- $137,800 - $206,800 a year
- Full-time
- Hybrid work
- 6 years
- Project management
- Bachelor's degree
- Loan repayment program
- Dental insurance
Archive Senior Specialist, Global Quality Systems and Compliance (Contract)
Vertex Pharmaceuticals —Boston, MA
- $46 - $49 an hour
- Temporary
- Microsoft Excel
- Mid-level
- 3 years
GMP Operational Quality Senior Specialist (Stability)
Vertex Pharmaceuticals —Boston, MA
- $94,200 - $141,200 a year
- Full-time
- Hybrid work
- 3 years
- Bachelor's degree
- Organizational skills
- Loan repayment program
- Dental insurance
Senior Manager, Operational Area Quality (Combination Products)
Vertex Pharmaceuticals —Boston, MA
- $133,800 - $200,600 a year
- Full-time
- Hybrid work
- Engineering
- Senior level
- Leadership
- Loan repayment program
- Dental insurance
Quality Senior Specialist - Finished Goods – Commercial (Contract) 29636
Vertex Pharmaceuticals —Boston, MA
- $55 - $65 an hour
- Full-time
- Mid-level
- 3 years
- Leadership
Senior Manager, Clinical Quality Assurance
Kura Oncology —Boston, MA
- $160,000 - $187,000 a year
- Remote
- 6 years
- Bachelor of Science
- Adults
- Paid parental leave
- Employee stock purchase plan
Senior Quality Director
Nova Biomedical —Waltham, MA
- $220,000 - $300,000 a year
- Full-time
- Hybrid work
- Ability to lift 50 pounds
- In-person
- Senior level
- Paid holidays
- Health insurance
Quick Apply
Supplier Quality Senior Specialist
Lantheus Medical Imaging Inc —Bedford, MA
- $111,000 - $185,000 a year
- Hybrid work
- Inventory management
- Bachelor of Science
- Databases
- Paid parental leave
- Paid holidays
Quick Apply
Senior Associate, Quality Systems
Replimune —Framingham, MA
- $101,500 - $131,500 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Mid-level
- Paid holidays
- Health insurance
Quick Apply
14d
Sr. Director, Quality Assurance for Quality Control
Vaxcyte —Boston, MA
- $229,000 - $268,000 a year
- Remote
- 11+ years
- Bachelor's degree
- Senior level
6d
Senior Scientist I, Quality Control
Candel Therapeutics —Needham, MA
- $155,000 - $160,000 a year
- Full-time
- Doctor of Philosophy
- US work authorization
- Computer skills
Sr. Manager, GMP Quality Assurance
Deciphera Pharmaceuticals —Waltham, MA
- $138,000 - $190,000 a year
- Full-time
- Remote
- 8 years
- Bachelor's degree
- Travel
- Health insurance
- Dental insurance
Quick Apply
Senior Quality Systems Specialist
ABCorp NA Inc. —Boston, MA
- $95,000 - $105,000 a year
- 5 years
- Senior level
Quick Apply
Senior Quality Engineer
Nova Biomedical —Billerica, MA
- $125,000 - $135,000 a year
- Full-time
- Hybrid work
- Ability to walk for extended periods
- 8 years
- Ability to lift 50 pounds
- Paid holidays
- Health insurance
Quick Apply
Senior Manager, Quality and Safety
Brigham and Women's Faulkner Hospital, Inc. —Boston, MA
- $99,465.60 - $144,643.20 a year
- Full-time
- Hybrid work
- Nursing
- Microsoft Excel
- Hospital
- Opportunities for advancement
Quick Apply
Senior QA Specialist
Editas Medicine —Cambridge, MA
- $110,000 - $120,000 a year
- Full-time
- Bachelor of Science
- Bachelor's degree
- Senior level
- Health savings account
- Disability insurance
Quick Apply
Senior Associate, Quality Assurance
Ocular Therapeutix —Bedford, MA
- $109,000 - $121,000 a year
- 5 years
- Computer literacy
- Data analysis skills
Senior Software QA Engineer
Nova Biomedical —Norwood, MA
- $120,000 - $130,000 a year
- Full-time
- Hybrid work
- Computer science
- Ability to lift 50 pounds
- Senior level
- Paid holidays
- Health insurance
Quick Apply
Senior Quality Engineer
Amgen —Cambridge, MA
- $118,435 - $140,781 a year
- Online Application
- Hybrid work
- Engineering
- 3 years
- Senior level
- Disability insurance
- Health insurance
14d
Senior Manager, GCP Quality Assurance
Olema Oncology —Boston, MA
- $160,000 - $180,000 a year
- Hybrid work
- Writing skills
- Office
- 8 years
Quick Apply

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Senior Manager, Clinical Study Quality Lead (Hybrid)

Vertex Pharmaceuticals -
Boston, MA

Apply Now

Job Details

Full-time
$137,800 - $206,800 a year

Benefits

Loan repayment program
Dental insurance
Tuition reimbursement
Paid time off
Vision insurance
401(k) matching

Qualifications

Quality control corrective actions
Risk management compliance audits
Investigations regulatory compliance
Defect resolution root cause analysis
Clinical trial risk management
Clinical research audit management
Preventive action implementation
Corrective and preventive actions (CAPA)
Internal investigations
Quality control audit
Clinical audit and monitoring
ICH guidelines
Project management
Regulatory readiness in healthcare
Audit risk assessments
Research regulatory compliance
Clinical quality assurance standards
Root cause analysis
Clinical program risk management
Cross-functional communication

Full Job Description

Job Description

General Summary:

The Senior Manager, Clinical Study Quality Lead provides study-level quality oversight for assigned clinical trials to help ensure they are conducted in compliance with Good Clinical Practice (GCP), applicable global regulations, study protocols, and Vertex procedures. This is an individual contributor role focused on GCP quality assurance oversight for clinical trials, including risk-based audit strategy, quality risk identification, issue escalation, CAPA support, compliance trend analysis, and inspection readiness. The role partners closely with clinical study teams and external stakeholders, including CROs, vendors, and investigator sites, to support quality outcomes across Vertex clinical programs. The ideal candidate brings direct, hands-on GCP QA experience supporting clinical trials in a sponsor, CRO, or similarly regulated clinical research environment. This position is on-site or hybrid and is not eligible for a fully remote work arrangement.

Key Duties and Responsibilities:

Serve as the Clinical Study Quality Lead for assigned trials, providing GCP QA oversight and guidance to clinical study teams and key stakeholders.
Partner cross-functionally with clinical study teams, CROs, vendors, and investigator sites to support quality oversight and maintain inspection readiness.
Conduct risk-based quality reviews of protocols, informed consent documents, and other key study documentation to identify potential compliance and operational risks.
Advise clinical study teams on quality risks and support the development of practical, risk-based mitigation strategies.
Develop and oversee investigator site audit plans for assigned studies, ensuring alignment with study risk, audit strategy, and company expectations.
Lead and/or support domestic and international investigator site audits and inspection readiness activities.
Review audit reports, responses, and CAPA plans to ensure findings are appropriately assessed, addressed, and resolved in a timely manner.
Support quality issue investigations, including root cause analysis, CAPA planning, and follow-up of effectiveness measures.
Review and monitor clinical quality data, compliance signals, and study-level trends, escalating significant risks or concerns as appropriate.
Contribute to ongoing process improvement and continuous quality initiatives to strengthen GCP compliance across clinical programs.
Support regulatory agency inspections at Vertex and/or clinical investigator sites, as needed.
May contribute to the review of SOPs, work instructions, and internal guidance documents that support the clinical quality management system.

Required Experience:

Bachelor’s degree and 6+ years of direct GCP Quality Assurance experience providing oversight for clinical trials, or the equivalent combination of education and experience.
Candidates must have direct, hands-on experience providing GCP QA oversight for clinical trials.
Experience supporting clinical study quality in a sponsor, CRO, or similarly regulated clinical research environment.
Experience supporting clinical development programs for drugs and biologics.

Required Knowledge/Skills:

Strong knowledge of ICH GCP E6(R3) and applicable global clinical trial regulations and guidance.
Demonstrated experience in GCP clinical trial quality oversight, including audit support, inspection readiness, quality issue management, root cause analysis, and CAPA.
Ability to identify GCP compliance risks, assess impact, and apply risk-based quality principles in a clinical trial environment.
Strong communication skills, with the ability to work effectively across internal and external stakeholders.
Ability to work independently, manage multiple priorities, and deliver high-quality work in a fast-paced environment.
Strong organizational, project management, and problem-solving skills.

Preferred Skills:

Experience supporting devices, combination products, or cell and gene therapy clinical trials.
Experience supporting GCP QA activities in a Phase 1 Clinical Research Unit is highly desirable.
Professional certification such as RQAP-GCP, CCRP, or similar.

Other Requirements:

Up to 10% travel may be required.

Pay Range:

$137,800 - $206,800

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid : work remotely up to two days per week; or select
2. On-Site : work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]

Apply Now

Refine Your Search

senior quality assurance jobs in boston ma

Senior Manager, Clinical Study Quality Lead (Hybrid)

Archive Senior Specialist, Global Quality Systems and Compliance (Contract)

GMP Operational Quality Senior Specialist (Stability)

Senior Manager, Operational Area Quality (Combination Products)

Quality Senior Specialist - Finished Goods – Commercial (Contract) 29636

Senior Manager, Clinical Quality Assurance

Senior Quality Director

Supplier Quality Senior Specialist

Senior Associate, Quality Systems

Sr. Director, Quality Assurance for Quality Control

Senior Scientist I, Quality Control

Sr. Manager, GMP Quality Assurance

Senior Quality Systems Specialist

Senior Quality Engineer

Senior Manager, Quality and Safety

Senior QA Specialist

Senior Associate, Quality Assurance

Senior Software QA Engineer

Senior Quality Engineer

Senior Manager, GCP Quality Assurance

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