Senior Director, Quality Systems/QMS
Vertex Pharmaceuticals
June 24, 2026
Remote friendly (Boston, MA)
United States
Operations
Key Responsibilities
- Provide strategic leadership/oversight to ensure global QMS health, integrity, and effectiveness across all GxP domains, products, modalities, and geographies.
- Align Quality Systems with global regulatory expectations; identify/assess/control QMS-level risks; drive quality-by-design and continuous improvement; ensure lessons learned become systemic improvements.
- Own and evolve the QSO/Quality Systems model and strategic roadmap (e.g., scaling, digital readiness, emerging technologies/novel modalities).
- Implement and govern the Quality Systems Ownership model; lead Quality Systems Owners accountable for cross-QMS quality systems (e.g., Quality Risk, Vendor Quality, Event, Knowledge, Data Integrity).
- Chair integrated Quality Systems governance (e.g., PONs; interfaces with operational governance such as QMR) and align internal/external (outsourced/third-party) standards and expectations.
- Model Quality Leadership; champion quality culture, transparency, and integrity; partner with QA and enterprise functions to translate into operating standards and inspection readiness.
- Lead, develop, and mentor quality professionals; act as change agent for QMS transformation (including digitization).
Required Qualifications
- BS/MS/JD/MD/PhD in Life Sciences (or equivalent).
- 15 years relevant experience; 7 years in global supervisory/leadership roles.
- GMP and/or GCP operational/quality oversight experience (additional breadth preferred).
- Built sustainable Quality Systems/QMS models and governance to ensure compliance across GxP.
In-depth Knowledge/Skills
- Strong knowledge of global regulations and ICH guidance; direct authority experience or multi-region health authority interactions.
- 10+ years QA leadership across audit/compliance/inspection/operational quality.
- Enterprise and cross-functional influence; strategic change leadership.
- Experience across preclinical, clinical, and CMC with quality/risk management principles.
- Process improvement (Lean, DMAIC, Six Sigma), problem-solving, data analysis.
- Travel up to 15%.
- Provide strategic leadership/oversight to ensure global QMS health, integrity, and effectiveness across all GxP domains, products, modalities, and geographies.
- Align Quality Systems with global regulatory expectations; identify/assess/control QMS-level risks; drive quality-by-design and continuous improvement; ensure lessons learned become systemic improvements.
- Own and evolve the QSO/Quality Systems model and strategic roadmap (e.g., scaling, digital readiness, emerging technologies/novel modalities).
- Implement and govern the Quality Systems Ownership model; lead Quality Systems Owners accountable for cross-QMS quality systems (e.g., Quality Risk, Vendor Quality, Event, Knowledge, Data Integrity).
- Chair integrated Quality Systems governance (e.g., PONs; interfaces with operational governance such as QMR) and align internal/external (outsourced/third-party) standards and expectations.
- Model Quality Leadership; champion quality culture, transparency, and integrity; partner with QA and enterprise functions to translate into operating standards and inspection readiness.
- Lead, develop, and mentor quality professionals; act as change agent for QMS transformation (including digitization).
Required Qualifications
- BS/MS/JD/MD/PhD in Life Sciences (or equivalent).
- 15 years relevant experience; 7 years in global supervisory/leadership roles.
- GMP and/or GCP operational/quality oversight experience (additional breadth preferred).
- Built sustainable Quality Systems/QMS models and governance to ensure compliance across GxP.
In-depth Knowledge/Skills
- Strong knowledge of global regulations and ICH guidance; direct authority experience or multi-region health authority interactions.
- 10+ years QA leadership across audit/compliance/inspection/operational quality.
- Enterprise and cross-functional influence; strategic change leadership.
- Experience across preclinical, clinical, and CMC with quality/risk management principles.
- Process improvement (Lean, DMAIC, Six Sigma), problem-solving, data analysis.
- Travel up to 15%.