Top 111 Quality assurance manager Jobs in Foxborough, Ma

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 Manager - Manufacturing
Search Staffing Group Inc. —Mansfield, MA
- $120,000 - $135,000 a year
- Full-time
- 5 years
- Bachelor of Science
- Engineering
- Health insurance
- 401(k)
Quick Apply
6d
Quality Manager - Manufacturing
Search Staffing Group Inc. —Franklin, MA
- $125,000 - $140,000 a year
- Full-time
- Bachelor of Science
- Engineering
- 8 years
- Health insurance
- 401(k)
Quick Apply
7d
Program Manager III, Network Quality
Dana-Farber Cancer Institute —Foxborough, MA
- $108,280 - $118,915 a year
- Full-time
- 7 years
- Research
- Analysis skills
10d
Sr. QC Manager
Nova Biomedical —Waltham, MA
- $150,000 - $170,000 a year
- Full-time
- 5 years
- Product management
- Ability to sit for extended periods
- Paid holidays
- Health insurance
Quick Apply
5d
Manager, Quality Assurance
Quest Diagnostics —Marlborough, MA
- $103,000 - $143,000 a year
- Full-time
- Bachelor's degree
- Military encouraged
- Senior level
- Employee stock purchase plan
- Disability insurance
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Sr Manager, Quality and Change Management
Hologic —Marlborough, MA
- $134,700 - $224,500 a year
- Engineering
- 8 years
- Senior level
Quality Assurance Manager
Dana-Farber Cancer Institute —Boston, MA
- $130,000 - $142,000 a year
- Full-time
- Analysis skills
- Bachelor's degree
- Mentoring
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
Manager, Quality Operations
Viridian Therapeutics, Inc. —Waltham, MA
- $118,000 - $145,000 a year
- Full-time
- Hybrid work
- Microsoft Excel
- Microsoft Outlook
- 5 years
- Paid parental leave
- AD&D insurance
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Quality Control Manager (External Operations)
Eli Lilly —Boston, MA
- $71,250 - $161,700 a year
- Overtime
- Hybrid work
- Bachelor of Science
- 3 years
- Bachelor's degree
- Health insurance
- Dental insurance
5d
Senior Manager, Quality Control GMP
Cogent Biosciences —Waltham, MA
- $155,000 - $185,000 a year
- Remote
- 5 years
- Bachelor of Science
- Bachelor's degree
- Free parking
- Paid parental leave
Quick Apply
10d
Quality Assurance Quality Control Manager
Zoll Medical Corporation —Pawtucket, RI
- $100,000 - $120,000 a year
- English
- Bachelor's degree
- Travel
Quality Systems Manager
Vor Bio —Boston, MA
- $170,000 - $180,000 a year
- 3 years
- Analysis skills
- Continuous improvement
- Health insurance
- 401(k)
Manager, GMP Quality Assurance, Clinical, QA
Agios Pharmaceuticals —Cambridge, MA
- $110,029 - $165,044 a year
- Remote
- 6 years
- Bachelor's degree
- Travel
- Health insurance
Manager, Clinical Quality Assurance
Alkermes, Inc. —Waltham, MA
- Full-time
- Mid-level
- Office
- Bachelor's degree
Manager, Quality Assurance Plant Operations
Roslin CT US Holdings,LLC —Hopkinton, MA
- $115,000 - $150,000 a year
- Full-time
- Microsoft Excel
- Management
- Supervising experience
Quick Apply
Quality Assurance Manager
Ardelyx —Waltham, MA
- $139,000 - $169,000 a year
- Full-time
- Hybrid work
- Office
- Bachelor's degree
- SharePoint
- Paid parental leave
- Paid holidays
Senior Manager, GCP Quality Assurance
Olema Oncology —Boston, MA
- $160,000 - $180,000 a year
- Hybrid work
- Writing skills
- Office
- 8 years
Quick Apply
International Quality Assurance Manager (Quality Management Systems)
AngioDynamics —Marlborough, MA
- $121,000 - $152,000 a year
- Full-time
- Office
- 3 years
- Ability to lift 50 pounds
Quick Apply

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Senior Manager, Operational Area Quality (Combination Products)

Vertex Pharmaceuticals -
Boston, MA

Apply Now

Job Details

Full-time
$133,800 - $200,600 a year

Benefits

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

Qualifications

Regulatory inspections
Statistics
Communication with suppliers
Investigations regulatory compliance
Quality records maintenance
Supplier corrective action implementation
Preventive action implementation
Engineering
Document control experience within manufacturing industry
Production deviation management
Quality control preventive actions
Corrective and preventive actions (CAPA)
GMP
Internal investigations
Quality improvement leadership
Minitab
Vendor compliance audits
Supplier audits
Vendor compliance management
Bachelor's degree in engineering
Production validation processes
Quality risk management
Medical device manufacturing facility experience
Pharmaceutical company experience
Design failure mode and effects analysis (DFMEA)
Technology transfer (scale-up process)
Compliance documentation
Supplier development
Leading team collaboration initiatives
Regulatory/legal compliance standards in production

Full Job Description

Job Description

General Summary

The Operational Area Quality Senior Manager provides quality leadership for assembly manufacturing operations supporting medical device and combination products. The role is responsible for quality oversight of manufacturing operations, product disposition, batch record review, deviations, investigations, CAPAs, change controls, supplier quality, and regulatory compliance while partnering with manufacturing, engineering, supply chain, and external manufacturing partners. The position also supports design quality activities to ensure manufacturing changes remain aligned with design control and risk management requirements throughout the product lifecycle.

Key Duties and Responsibilities

Lead Quality Assurance support for assembly manufacturing operations of medical device and combination products, ensuring compliance with GMP, regulatory requirements, and internal quality systems.
Provide quality oversight for product disposition activities, including review and approval of manufacturing documentation to support timely release of clinical and commercial product.
Review and approve Manufacturing Batch Records (MBRs), Electronic Batch Records (EBRs), Device History Records (DHRs), and associated manufacturing documentation.
Lead and approve manufacturing deviations, investigations, nonconforming material reports (NCMRs), CAPAs, change controls, and effectiveness checks.
Conduct and lead root cause investigations using structured problem-solving methodologies and ensure implementation of effective corrective and preventive actions.
Support manufacturing operations by providing real-time quality oversight for assembly processes, equipment issues, process improvements, and manufacturing investigations.
Partner with Contract Manufacturing Organizations (CMOs) to ensure compliance with Quality Agreements, disposition requirements, manufacturing investigations, and continuous improvement initiatives.
Support manufacturing process validation, equipment qualification, technology transfers, and process improvements to ensure products remain in a validated state.
Lead supplier quality activities including supplier investigations, supplier change assessments, supplier qualification, and quality issue resolution.
Support regulatory inspections, customer audits, supplier audits, and internal audits while ensuring timely responses and closure of observations.
Support complaint investigations and product quality assessments as required.
Support Design Quality activities by reviewing design changes, participating in design reviews, supporting Design History File maintenance, and ensuring manufacturing changes are appropriately evaluated through design controls and risk management.
Provide input into risk management activities, including DFMEA, PFMEA, hazard analyses, and Risk Management Files, to ensure manufacturing risks are appropriately evaluated throughout the product lifecycle.

Knowledge and Skills

Strong experience supporting assembly manufacturing operations for medical devices and combination products.
Demonstrated experience reviewing and approving MBRs, EBRs, DHRs, product disposition, manufacturing investigations, CAPAs, deviations, change controls, and nonconforming material records.
Strong knowledge of autoinjector and drug-device combination products, including assembly processes, manufacturing operations, supplier management, and product lifecycle support.
Demonstrated knowledge of GMP, 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and applicable combination product regulations.
Experience supporting process validation, equipment qualification, technology transfers, and manufacturing readiness.
Experience working with Contract Manufacturing Organizations (CMOs) and external suppliers.
Working knowledge of Design Controls and Risk Management to support manufacturing quality activities and lifecycle changes.
Strong technical problem-solving, investigation, and root cause analysis skills.
Excellent leadership, communication, and cross-functional collaboration skills.
Experience with statistical analysis tools, Minitab, and quality engineering methodologies preferred.

Education and Experience

Bachelor’s degree in Engineering, Life Sciences, Quality, Manufacturing, or a related technical discipline is required. Advanced degree preferred.
Typically requires 10+ years of Quality Assurance, Quality Engineering, Manufacturing Quality, or Operations Quality experience within the medical device, biotechnology, pharmaceutical, or combination product industry.
Minimum of 5 years supporting GMP manufacturing operations, including assembly manufacturing, product disposition, deviation management, investigations, CAPA, change control, and batch record review.
Demonstrated experience supporting autoinjector, prefilled syringe, or other drug-device combination products from clinical through commercial manufacturing.
Experience leading cross-functional quality initiatives and partnering with Contract Manufacturing Organizations (CMOs) and suppliers.
Prior people leadership or demonstrated technical leadership of complex quality programs is preferred

Pay Range:

$133,800 - $200,600

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

quality assurance manager jobs in foxborough, ma

Senior Manager, Operational Area Quality (Combination Products)

Quality Manager - Manufacturing

Quality Manager - Manufacturing

Program Manager III, Network Quality

Sr. QC Manager

Manager, Quality Assurance

Sr Manager, Quality and Change Management

Quality Assurance Manager

Sr. Manager, GMP Quality Assurance

Manager, Quality Operations

Quality Control Manager (External Operations)

Senior Manager, Quality Control GMP

Quality Assurance Quality Control Manager

Quality Systems Manager

Manager, GMP Quality Assurance, Clinical, QA

Manager, Clinical Quality Assurance

Manager, Quality Assurance Plant Operations

Quality Assurance Manager

Senior Manager, GCP Quality Assurance

International Quality Assurance Manager (Quality Management Systems)

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