Senior Director, Quality Systems/QMS
Vertex Pharmaceuticals
August 29, 2026
Remote friendly (Boston, MA)
United States
Operations
Key Responsibilities
- Provide strategic leadership and oversight to ensure global QMS health, integrity, and effectiveness across GxP domains, products/modality, and geographies.
- Ensure QS alignment with global regulatory expectations; identify, assess, and control QMS-level risks; drive quality-by-design and continuous improvement.
- Own the QSO/Quality Systems model and strategic roadmap for evolution (e.g., scaling, digital enablement, emerging technologies/novel modalities).
- Implement and govern the Quality Systems Ownership model; lead a team of Quality Systems Owners (e.g., Quality Risk Management, Vendor Quality Management, Event Management, Knowledge Management, Data Integrity).
- Chair/lead integrated QMS governance (e.g., PONs and QS governance interfaces with operational governance such as QMR).
- Role model Quality Leadership; partner with QA and enterprise functions to translate strategy into operating standards and inspection readiness.
- Lead, develop, and mentor quality professionals; serve as change agent for transformation (digitization/advanced technology integration).
Required Qualifications / Skills
- BS/MS/JD/MD/PhD in Life Sciences (or equivalent); 15+ years relevant experience with 7+ years in supervisory leadership (global organization).
- Operational/quality oversight experience (GMP and/or GCP preferred); enterprise-level and cross-functional experience.
- Experience building sustainable QMS models/oversight programs and governance across GxP.
- In-depth knowledge of global regulations/ICH guidance; direct regulator authority experience or strong health authority interaction.
- 10+ years QA leadership across audit, compliance, inspection, and operational quality management.
- Demonstrated stakeholder influence/enterprise thinking; strong communication skills.
- Experience across preclinical, clinical, and CMC with quality/risk management application.
- Root-cause, Lean/DMAIC/Six Sigma; strong problem-solving/data analysis.
- Ability to travel up to 15%.
- Provide strategic leadership and oversight to ensure global QMS health, integrity, and effectiveness across GxP domains, products/modality, and geographies.
- Ensure QS alignment with global regulatory expectations; identify, assess, and control QMS-level risks; drive quality-by-design and continuous improvement.
- Own the QSO/Quality Systems model and strategic roadmap for evolution (e.g., scaling, digital enablement, emerging technologies/novel modalities).
- Implement and govern the Quality Systems Ownership model; lead a team of Quality Systems Owners (e.g., Quality Risk Management, Vendor Quality Management, Event Management, Knowledge Management, Data Integrity).
- Chair/lead integrated QMS governance (e.g., PONs and QS governance interfaces with operational governance such as QMR).
- Role model Quality Leadership; partner with QA and enterprise functions to translate strategy into operating standards and inspection readiness.
- Lead, develop, and mentor quality professionals; serve as change agent for transformation (digitization/advanced technology integration).
Required Qualifications / Skills
- BS/MS/JD/MD/PhD in Life Sciences (or equivalent); 15+ years relevant experience with 7+ years in supervisory leadership (global organization).
- Operational/quality oversight experience (GMP and/or GCP preferred); enterprise-level and cross-functional experience.
- Experience building sustainable QMS models/oversight programs and governance across GxP.
- In-depth knowledge of global regulations/ICH guidance; direct regulator authority experience or strong health authority interaction.
- 10+ years QA leadership across audit, compliance, inspection, and operational quality management.
- Demonstrated stakeholder influence/enterprise thinking; strong communication skills.
- Experience across preclinical, clinical, and CMC with quality/risk management application.
- Root-cause, Lean/DMAIC/Six Sigma; strong problem-solving/data analysis.
- Ability to travel up to 15%.