QA Manager- Finished Goods Commercial
Vertex Pharmaceuticals
June 27, 2026
Remote friendly (Boston, MA)
United States
Operations
General Summary:
The Quality Manager provides oversight of department activities, ensuring alignment with corporate goals and regulatory requirements. Manages complex projects, troubleshoots issues, and collaborates with business partners to ensure supply continuity in all markets. Oversees end-to-end Finished Goods product disposition, ensuring timely and compliant release through data readiness and continuous improvement with CMOs and internal teams.
Key Responsibilities
Product Disposition Management
- Oversee Finished Goods disposition to meet regulatory/quality standards.
- Collaborate with CMOs to resolve disposition issues and align on timelines/quality expectations.
- Review Executed Batch Records (EBRs) for commercial packaging and resolve CMO comments.
- Review impacting change controls vs. full lot genealogy to decide material compliance by region, make disposition decisions, and perform batch release.
- Evaluate Investigations/OOS/Change Controls for disposition decisions; assist with EAC/Material Review Board as needed.
- Manage data readiness (batch records, CoA, supporting documentation) and proactively improve processes to meet turnaround times.
Stakeholder Collaboration
- Lead/manage QA relationships with one or more CMOs as CMO lead; serve as primary QA contact for disposition queries/escalations.
- Collaborate with internal teams (MS&T, External Manufacturing, Supply Chain, Regulatory) to resolve quality events.
Compliance and Continuous Improvement / Communication / Audit Support
- Provide guidance for root-cause, impact assessments, and CAPA; support GMP/GDP reviews, risk assessments, and mitigation.
- Identify process improvements; lead/represent FG QA in continuous improvement initiatives.
- Prepare operational/quality reports and updates; serve as SME for audit/inspection preparation and execution.
Minimum Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, or related health field.
- 4+ years in pharmaceutical manufacturing (Packaging/Labelling preferred), QA, or Finished Goods disposition.
- Strong global GMP knowledge for oral drug products; proficiency in data analysis/visualization.
- Excellent communication, collaboration, and project management.
Preferred Qualifications (selection)
- Leadership in high-throughput environments; strong attention to detail.
- Critical thinking/problem solving; risk-based decision-making.
- Project management/continuous improvement; independent and cross-functional team leadership; mentoring.
- Expert knowledge of global GMP/GDP, root-cause analysis tools, broad GxP lifecycle knowledge.
Pay Range: $118,400 - $177,600.
The Quality Manager provides oversight of department activities, ensuring alignment with corporate goals and regulatory requirements. Manages complex projects, troubleshoots issues, and collaborates with business partners to ensure supply continuity in all markets. Oversees end-to-end Finished Goods product disposition, ensuring timely and compliant release through data readiness and continuous improvement with CMOs and internal teams.
Key Responsibilities
Product Disposition Management
- Oversee Finished Goods disposition to meet regulatory/quality standards.
- Collaborate with CMOs to resolve disposition issues and align on timelines/quality expectations.
- Review Executed Batch Records (EBRs) for commercial packaging and resolve CMO comments.
- Review impacting change controls vs. full lot genealogy to decide material compliance by region, make disposition decisions, and perform batch release.
- Evaluate Investigations/OOS/Change Controls for disposition decisions; assist with EAC/Material Review Board as needed.
- Manage data readiness (batch records, CoA, supporting documentation) and proactively improve processes to meet turnaround times.
Stakeholder Collaboration
- Lead/manage QA relationships with one or more CMOs as CMO lead; serve as primary QA contact for disposition queries/escalations.
- Collaborate with internal teams (MS&T, External Manufacturing, Supply Chain, Regulatory) to resolve quality events.
Compliance and Continuous Improvement / Communication / Audit Support
- Provide guidance for root-cause, impact assessments, and CAPA; support GMP/GDP reviews, risk assessments, and mitigation.
- Identify process improvements; lead/represent FG QA in continuous improvement initiatives.
- Prepare operational/quality reports and updates; serve as SME for audit/inspection preparation and execution.
Minimum Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, or related health field.
- 4+ years in pharmaceutical manufacturing (Packaging/Labelling preferred), QA, or Finished Goods disposition.
- Strong global GMP knowledge for oral drug products; proficiency in data analysis/visualization.
- Excellent communication, collaboration, and project management.
Preferred Qualifications (selection)
- Leadership in high-throughput environments; strong attention to detail.
- Critical thinking/problem solving; risk-based decision-making.
- Project management/continuous improvement; independent and cross-functional team leadership; mentoring.
- Expert knowledge of global GMP/GDP, root-cause analysis tools, broad GxP lifecycle knowledge.
Pay Range: $118,400 - $177,600.