Quality Assurance Lead Jobs in Boston, MA
Quality Assurance Lead jobs in Boston concentrate in the Longwood Medical Area, the Seaport District, and Kendall Square-adjacent employers just across the river, with demand driven by life sciences, medtech, and enterprise software. Employers actively hiring include Vertex Pharmaceuticals, PwC, and CarGurus. Find a role that fits below and apply directly.
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Showing 5 of 66+ Quality Assurance Lead jobs
Job Description
General Summary:
The Manufacturing Process & Technical Quality Associate Director provides end-to-end l quality oversight for cell and gene therapy programs across clinical development, commercialization, product launch, and post-approval lifecycle management. The role is responsible for establishing product quality standards for both established and emerging technologies, ensuring alignment with regulatory expectations and industry best practices, and proactively identifying and mitigating product quality risks throughout the product lifecycle and end to end patient journey.
This position partners closely with Manufacturing, Technical Operations, Regulatory Affairs, and Quality stakeholders to support program execution and governance, ensuring business, regulatory, quality, and operational objectives are achieved while maintaining the highest standards of patient safety and product quality.
Key Duties and Responsibilities:
Process Lifecycle Management
Serve as a Quality Assurance Subject Matter Expert (SME) for product and process lifecycle management, ensuring compliance with GxP regulations, and Vertex Quality Management System (QMS) including personalized medicine requirements.
Lead QA review and approval of stage-gate deliverables, process development activities, technology transfers, process validations, and new product introductions across the product lifecycle.
Drive the development, implementation, and maintenance of quality and compliance frameworks, standards, and strategies to ensure products and processes remain aligned with evolving regulatory and industry CGT expectations.
Partner with Development, Technical Operations, Manufacturing, and Supply Chain functions to support continuous improvement initiatives throughout development to commercialization.
Support preparation and review of process-related specifications, development reports, validation documentation, and regulatory submissions, including responses to Health Authority inquiries.
Serve as the Quality representative on CMC Governance forums to ensure compliant lifecycle strategies, technical transfers, and manufacturing changes.
Compliance & Investigations
Lead and/or support quality review of complex investigations, deviations, change controls, risk assessments, and compliance issues impacting product quality or manufacturing processes.
Partner with cross-functional teams to identify product, process and quality and compliance risks, assess impact, and implement appropriate mitigation strategies.
Support inspection readiness activities and participate in Health Authority inspections, regulatory interactions, information requests, and corrective action commitments.
Support development of Vertex quality systems and processes.
Identify, facilitate, and/or lead continuous improvement efforts
Technical Operations & CMO Management
Provide Quality oversight and strategic partnership for internal manufacturing operations and external contract manufacturing organizations (CMOs) supporting product lifecycle activities.
Support implementation of standardized quality practices, lifecycle management strategies, and continuous improvement initiatives across internal and external manufacturing networks.
Digital & Artificial Intelligence
Demonstrate understanding of digital manufacturing, process lifecycle management platforms, data analytics, automation technologies, and emerging AI applications within regulated GxP environments.
Utilize digital tools, advanced analytics, and AI-enabled solutions to enhance quality oversight, risk management, process monitoring, and operational decision-making.
Leverage systems such as MES, eQMS, data visualization platforms, process monitoring tools, and advanced analytics to assess product quality performance throughout the lifecycle
Knowledge and Skills:
- In-depth global regulatory agency and technical knowledge and experience across GXP QA and QC activities in cell therapies
- Experience with platforms such as MES, LIMS, eQMS, data visualization tools, and advanced analytics is preferred.
- Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience.
- Enterprise Impact & Influence with the ability to shape decisions across the organization through strong partnerships, communication, and presence.
- Critical Thinking and Problem Solving skills
Education and Experience:
- Bachelor’s degree in a scientific or allied health field (or equivalent degree)
- Preferred additional Master’s degree at Business /Scientific level
- 8+ years of experience, or the equivalent combination of education and experience in a regulated pharmaceutical environment.
#LI-Hybrid
Pay Range:
$156,600 - $234,800Disclosure 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 EligibleFlex 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 ApplicationAssistance@vrtx.com
Job Description
General Summary:
The Manufacturing Process & Technical Quality Associate Director provides end-to-end l quality oversight for cell and gene therapy programs across clinical development, commercialization, product launch, and post-approval lifecycle management. The role is responsible for establishing product quality standards for both established and emerging technologies, ensuring alignment with regulatory expectations and industry best practices, and proactively identifying and mitigating product quality risks throughout the product lifecycle and end to end patient journey.
This position partners closely with Manufacturing, Technical Operations, Regulatory Affairs, and Quality stakeholders to support program execution and governance, ensuring business, regulatory, quality, and operational objectives are achieved while maintaining the highest standards of patient safety and product quality.
Key Duties and Responsibilities:
Process Lifecycle Management
Serve as a Quality Assurance Subject Matter Expert (SME) for product and process lifecycle management, ensuring compliance with GxP regulations, and Vertex Quality Management System (QMS) including personalized medicine requirements.
Lead QA review and approval of stage-gate deliverables, process development activities, technology transfers, process validations, and new product introductions across the product lifecycle.
Drive the development, implementation, and maintenance of quality and compliance frameworks, standards, and strategies to ensure products and processes remain aligned with evolving regulatory and industry CGT expectations.
Partner with Development, Technical Operations, Manufacturing, and Supply Chain functions to support continuous improvement initiatives throughout development to commercialization.
Support preparation and review of process-related specifications, development reports, validation documentation, and regulatory submissions, including responses to Health Authority inquiries.
Serve as the Quality representative on CMC Governance forums to ensure compliant lifecycle strategies, technical transfers, and manufacturing changes.
Compliance & Investigations
Lead and/or support quality review of complex investigations, deviations, change controls, risk assessments, and compliance issues impacting product quality or manufacturing processes.
Partner with cross-functional teams to identify product, process and quality and compliance risks, assess impact, and implement appropriate mitigation strategies.
Support inspection readiness activities and participate in Health Authority inspections, regulatory interactions, information requests, and corrective action commitments.
Support development of Vertex quality systems and processes.
Identify, facilitate, and/or lead continuous improvement efforts
Technical Operations & CMO Management
Provide Quality oversight and strategic partnership for internal manufacturing operations and external contract manufacturing organizations (CMOs) supporting product lifecycle activities.
Support implementation of standardized quality practices, lifecycle management strategies, and continuous improvement initiatives across internal and external manufacturing networks.
Digital & Artificial Intelligence
Demonstrate understanding of digital manufacturing, process lifecycle management platforms, data analytics, automation technologies, and emerging AI applications within regulated GxP environments.
Utilize digital tools, advanced analytics, and AI-enabled solutions to enhance quality oversight, risk management, process monitoring, and operational decision-making.
Leverage systems such as MES, eQMS, data visualization platforms, process monitoring tools, and advanced analytics to assess product quality performance throughout the lifecycle
Knowledge and Skills:
- In-depth global regulatory agency and technical knowledge and experience across GXP QA and QC activities in cell therapies
- Experience with platforms such as MES, LIMS, eQMS, data visualization tools, and advanced analytics is preferred.
- Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience.
- Enterprise Impact & Influence with the ability to shape decisions across the organization through strong partnerships, communication, and presence.
- Critical Thinking and Problem Solving skills
Education and Experience:
- Bachelor’s degree in a scientific or allied health field (or equivalent degree)
- Preferred additional Master’s degree at Business /Scientific level
- 8+ years of experience, or the equivalent combination of education and experience in a regulated pharmaceutical environment.
#LI-Hybrid
Pay Range:
$156,600 - $234,800Disclosure 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 EligibleFlex 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 ApplicationAssistance@vrtx.com
See All 66 Quality Assurance Lead Jobs in Boston
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Find Quality Assurance Lead JobsQuality Assurance Lead Job Market in Boston
Who's Hiring
Top Industries Hiring
- Technology & Software
- Healthcare & Medical Services
- Consulting & Professional Services
Quality Assurance Lead Jobs in Boston: Frequently Asked Questions
How do I get a quality assurance lead job in Boston?
Boston's strongest hiring comes from life sciences companies in the Longwood Medical Area, medtech firms in the Seaport, and software companies near Kendall Square. Candidates with hands-on experience in FDA-regulated environments or Agile QA frameworks stand out here. Building familiarity with validation protocols used in biotech and medical devices gives you a concrete edge over generalist applicants in this market.
Which companies hire quality assurance leads in Boston?
Employers hiring quality assurance leads in Boston right now include Vertex Pharmaceuticals, PwC, and CarGurus, based on current listings on Migrate Mate as of August 2026. Boston's hiring pool skews toward life sciences, medtech, and enterprise software companies, many of which maintain dedicated QA functions at their local offices or innovation hubs.
Are there remote quality assurance lead jobs in Boston?
Yes, though availability depends on the role type. Analytical and process-oversight QA lead positions tend to be remote-friendly, while roles tied to lab environments or physical product testing are almost always on-site. About 43% of quality assurance lead openings tied to Boston are remote or hybrid as of August 2026, with the most flexibility showing up in software and digital health companies headquartered in the Seaport and Innovation District.
How can I get a quality assurance lead job in Boston with little or no experience?
The most realistic entry path in Boston is moving into a QA analyst or junior QA engineer role at a software startup or medtech company, then building toward a lead title. Boston's dense life sciences ecosystem creates openings for candidates who complete validation or CAPA training, even without years of direct lead experience. Contract and temp-to-perm QA roles at CROs and biotech firms in the Longwood corridor regularly serve as stepping stones to permanent lead positions.
Which industries hire the most quality assurance leads in Boston?
Boston quality assurance lead roles concentrate in Technology & Software, Healthcare & Medical Services, and Consulting & Professional Services, based on current listings on Migrate Mate as of August 2026. Boston's position as a global hub for life sciences and academic medical institutions creates consistent, year-round demand for QA professionals who understand both regulated and agile product environments.
Related Jobs in Massachusetts
See All 66 Quality Assurance Lead Jobs in Boston
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