GMP Operational Quality Manager
Vertex Pharmaceuticals
June 27, 2026
Remote friendly (Boston, MA)
United States
Operations
Key Responsibilities:
- Participate in cross-functional teams as a Quality technical resource, providing quality oversight and support to analytical testing at contracted suppliers.
- Draft and enforce Quality Agreements between CMOs/Suppliers and Vertex.
- Assist Change Control owners to ensure compliance with change procedure requirements; assess and approve change controls.
- Conduct quality investigations/deviations; review corrective action plans for adequacy and compliance, including root cause analysis and product impact assessments for deviations and OOS.
- Ensure appropriate CAPA actions are identified and addressed; approve investigations/CAPAs.
- Identify, facilitate, and/or lead continuous improvement efforts.
- Maintain Quality Metrics to support process improvement.
- Conduct GMP document review (procedures, work instructions, specifications, methods, protocols, and method reports).
- Perform disposition activities for Commercial products.
- Coordinate, facilitate, and follow up on QLT action items.
- Identify and communicate risks and assist with risk mitigation plans.
- Support internal/external audit programs; assist with audit responses.
- Manage audit CAPAs and metrics; provide technical advice for partner/regulatory agency audits.
Minimum Qualifications (Knowledge and Skills):
- In-depth knowledge of cGMPs and global GMP requirements for pharmaceutical manufacturing and analytical lab testing.
- Strong leadership; able to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives.
- Experience leading complex projects/teams and continuous improvement; applies project management tools to facilitate planning and task completion.
- Ability to independently lead cross-functional teams and represent the Quality unit.
- Ability to mentor/guide staff; transfer technical knowledge.
- Strong cross-functional communication and influence.
- Ability to evaluate quality matters and make complex decisions using technical experience and advanced judgment.
- Strong experience with investigations, RCA, and CAPA.
- Experience with electronic document management systems (e.g., Veeva).
Education and Experience:
- Bachelor’s degree in a scientific or allied health field with 5+ years relevant experience (or equivalent).
- Experience providing Quality oversight of GMP manufacturing, including batch disposition.
- Experience with drug substance, spray dried dispersion (SDD), and drug product development/manufacturing (oral solid dosage forms preferred).
- Knowledge of cGMP requirements governing oral drug products manufacturing practices.
- Participate in cross-functional teams as a Quality technical resource, providing quality oversight and support to analytical testing at contracted suppliers.
- Draft and enforce Quality Agreements between CMOs/Suppliers and Vertex.
- Assist Change Control owners to ensure compliance with change procedure requirements; assess and approve change controls.
- Conduct quality investigations/deviations; review corrective action plans for adequacy and compliance, including root cause analysis and product impact assessments for deviations and OOS.
- Ensure appropriate CAPA actions are identified and addressed; approve investigations/CAPAs.
- Identify, facilitate, and/or lead continuous improvement efforts.
- Maintain Quality Metrics to support process improvement.
- Conduct GMP document review (procedures, work instructions, specifications, methods, protocols, and method reports).
- Perform disposition activities for Commercial products.
- Coordinate, facilitate, and follow up on QLT action items.
- Identify and communicate risks and assist with risk mitigation plans.
- Support internal/external audit programs; assist with audit responses.
- Manage audit CAPAs and metrics; provide technical advice for partner/regulatory agency audits.
Minimum Qualifications (Knowledge and Skills):
- In-depth knowledge of cGMPs and global GMP requirements for pharmaceutical manufacturing and analytical lab testing.
- Strong leadership; able to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives.
- Experience leading complex projects/teams and continuous improvement; applies project management tools to facilitate planning and task completion.
- Ability to independently lead cross-functional teams and represent the Quality unit.
- Ability to mentor/guide staff; transfer technical knowledge.
- Strong cross-functional communication and influence.
- Ability to evaluate quality matters and make complex decisions using technical experience and advanced judgment.
- Strong experience with investigations, RCA, and CAPA.
- Experience with electronic document management systems (e.g., Veeva).
Education and Experience:
- Bachelor’s degree in a scientific or allied health field with 5+ years relevant experience (or equivalent).
- Experience providing Quality oversight of GMP manufacturing, including batch disposition.
- Experience with drug substance, spray dried dispersion (SDD), and drug product development/manufacturing (oral solid dosage forms preferred).
- Knowledge of cGMP requirements governing oral drug products manufacturing practices.