Senior Director, Quality Systems/QMS
Vertex Pharmaceuticals
August 07, 2026
Remote friendly (Boston, MA)
United States
Operations
Position Summary:
The Senior Director, Global Quality Systems provides strategic vision and direction to advance and sustain the Quality Management System (QMS), ensuring its integrity, effectiveness, and robust execution across GxP domains, products, modalities, and geographies.
Key Responsibilities:
- Quality Management System Leadership: Provide strategic leadership to ensure global QMS health, integrity, and effectiveness; align QS with global regulatory expectations via fit-for-purpose standards; identify, assess, and control QMS-level risks; drive quality-by-design, continuous improvement, and systemic lessons learned; own the QSO/Quality Systems model and strategic roadmap.
- Quality Systems Oversight and Strategic Direction: Implement and govern the Quality Systems Ownership model; lead Quality Systems Owners accountable for cross-QMS quality systems (e.g., Quality Risk Management, Vendor Quality Management, Event Management, Knowledge Management, Data Integrity); chair integrated quality oversight/governance (e.g., PONs, QMR); align internal and external (outsourced/third party) QS standards and governance.
- Quality Leadership & Change Management: Role model enterprise quality leadership and culture; partner with QA leadership and functions (e.g., Finance, Strategic Sourcing, HR) on standards and inspection/compliance readiness; lead, develop, and mentor quality professionals; act as change agent for QMS transformation (digitization, advanced technology integration).
Required Qualifications:
- BS/MS/JD/MD/PhD in Life Sciences or equivalent; 15 years relevant experience with 7 years in global leadership/supervisory roles.
- GMP and/or GCP oversight experience (broader preferred); enterprise-level and cross-operational experience.
- Experience building sustainable advanced oversight programs/QMS models and governance for GxP compliance.
In-depth Knowledge/Skills:
- Global regulations and ICH guidance; regulatory authority or health authority interaction experience.
- 10+ years QA leadership in audit/compliance/inspection/operational quality management (sponsor or contract org).
- Strong enterprise cross-functional stakeholder influence; strategic change leadership.
- Experience across preclinical, clinical, and CMC; quality and risk management across GxP.
- Operational excellence (root cause, Lean/DMAIC/Six Sigma); strong problem-solving and data analysis.
- Travel up to 15%.
The Senior Director, Global Quality Systems provides strategic vision and direction to advance and sustain the Quality Management System (QMS), ensuring its integrity, effectiveness, and robust execution across GxP domains, products, modalities, and geographies.
Key Responsibilities:
- Quality Management System Leadership: Provide strategic leadership to ensure global QMS health, integrity, and effectiveness; align QS with global regulatory expectations via fit-for-purpose standards; identify, assess, and control QMS-level risks; drive quality-by-design, continuous improvement, and systemic lessons learned; own the QSO/Quality Systems model and strategic roadmap.
- Quality Systems Oversight and Strategic Direction: Implement and govern the Quality Systems Ownership model; lead Quality Systems Owners accountable for cross-QMS quality systems (e.g., Quality Risk Management, Vendor Quality Management, Event Management, Knowledge Management, Data Integrity); chair integrated quality oversight/governance (e.g., PONs, QMR); align internal and external (outsourced/third party) QS standards and governance.
- Quality Leadership & Change Management: Role model enterprise quality leadership and culture; partner with QA leadership and functions (e.g., Finance, Strategic Sourcing, HR) on standards and inspection/compliance readiness; lead, develop, and mentor quality professionals; act as change agent for QMS transformation (digitization, advanced technology integration).
Required Qualifications:
- BS/MS/JD/MD/PhD in Life Sciences or equivalent; 15 years relevant experience with 7 years in global leadership/supervisory roles.
- GMP and/or GCP oversight experience (broader preferred); enterprise-level and cross-operational experience.
- Experience building sustainable advanced oversight programs/QMS models and governance for GxP compliance.
In-depth Knowledge/Skills:
- Global regulations and ICH guidance; regulatory authority or health authority interaction experience.
- 10+ years QA leadership in audit/compliance/inspection/operational quality management (sponsor or contract org).
- Strong enterprise cross-functional stakeholder influence; strategic change leadership.
- Experience across preclinical, clinical, and CMC; quality and risk management across GxP.
- Operational excellence (root cause, Lean/DMAIC/Six Sigma); strong problem-solving and data analysis.
- Travel up to 15%.