Senior Director, Manufacturing Technical Sciences Quality Assurance (Hybrid)
Vertex Pharmaceuticals
June 27, 2026
Remote friendly (Boston, MA)
United States
Operations
General/Position Summary
- Senior Director, Manufacturing Technical Sciences QA provides end-to-end technical quality oversight for cell and genetic programs across clinical development, commercialization, product launch, and post-approval lifecycle.
- Leads a team of process and analytical QA personnel and partners with operational stakeholders on governance and quality oversight for technical change management.
- Hybrid role: minimum 3 days/week on-site in Boston Seaport.
Key Duties & Responsibilities
- Lead/develop/implement quality compliance principles and standardized processes across manufacturing sites.
- Develop CMC and analytical quality standards for stage-gate deliverables; maintain QA oversight for analytical/technical quality.
- Lead QA technical oversight through Change Management to ensure regulatory/product submission compliance pre/post implementation.
- Serve as CMC Quality SME for analytical/process development, technical transfers, and new product introduction.
- Oversee stability program compliance with internal procedures and EU/US regulations.
- Ensure quality/compliance frameworks align with industry/health authority expectations and the QMS.
- Drive continuous manufacturing/compliance improvements; identify and mitigate quality risks; support OOS investigations and spec justifications; prepare CMC clinical/commercial submissions.
- Support Health Authority inspections and drive CAPA; lead and mentor team; manage budget.
Required Education
- BS or MS in biotech/technical life science/engineering.
Required Experience
- 15+ years relevant biotech/regulated pharma manufacturing/QA/QC experience.
- 10+ years leadership/resource allocation; experience on Site/Quality Leadership Teams.
Required Skills/Knowledge
- Global regulatory (GXP) experience in cell/gene therapy/biologics (ICH/EU/FDA).
- On-site manufacturing and CDMO oversight experience; clinical-to-commercial lifecycle management.
- Regulator exposure (NDA/BLA/MAA submissions/inspections).
- Cell/aseptic processing/process & analytical development/manufacturing science knowledge.
- Root cause analysis, data analytics, Operational Excellence (LEAN/DMAIC/Six Sigma).
- Strong communication, critical thinking, and matrix leadership to build quality culture.
Other Requirements
- 15% international travel.
- Pay range: $216,000–$324,000.
- Senior Director, Manufacturing Technical Sciences QA provides end-to-end technical quality oversight for cell and genetic programs across clinical development, commercialization, product launch, and post-approval lifecycle.
- Leads a team of process and analytical QA personnel and partners with operational stakeholders on governance and quality oversight for technical change management.
- Hybrid role: minimum 3 days/week on-site in Boston Seaport.
Key Duties & Responsibilities
- Lead/develop/implement quality compliance principles and standardized processes across manufacturing sites.
- Develop CMC and analytical quality standards for stage-gate deliverables; maintain QA oversight for analytical/technical quality.
- Lead QA technical oversight through Change Management to ensure regulatory/product submission compliance pre/post implementation.
- Serve as CMC Quality SME for analytical/process development, technical transfers, and new product introduction.
- Oversee stability program compliance with internal procedures and EU/US regulations.
- Ensure quality/compliance frameworks align with industry/health authority expectations and the QMS.
- Drive continuous manufacturing/compliance improvements; identify and mitigate quality risks; support OOS investigations and spec justifications; prepare CMC clinical/commercial submissions.
- Support Health Authority inspections and drive CAPA; lead and mentor team; manage budget.
Required Education
- BS or MS in biotech/technical life science/engineering.
Required Experience
- 15+ years relevant biotech/regulated pharma manufacturing/QA/QC experience.
- 10+ years leadership/resource allocation; experience on Site/Quality Leadership Teams.
Required Skills/Knowledge
- Global regulatory (GXP) experience in cell/gene therapy/biologics (ICH/EU/FDA).
- On-site manufacturing and CDMO oversight experience; clinical-to-commercial lifecycle management.
- Regulator exposure (NDA/BLA/MAA submissions/inspections).
- Cell/aseptic processing/process & analytical development/manufacturing science knowledge.
- Root cause analysis, data analytics, Operational Excellence (LEAN/DMAIC/Six Sigma).
- Strong communication, critical thinking, and matrix leadership to build quality culture.
Other Requirements
- 15% international travel.
- Pay range: $216,000–$324,000.