Job Description
General Summary:
The Senior Director, Device Quality provides strategic Quality leadership and oversight for Vertex device and combination product operations across development, manufacturing, testing, clinical, commercial, and post-market activities.
The role is accountable for risk-based operational Quality oversight of internal activities and external partners , including CDMOs, testing laboratories, and critical suppliers. The role ensures compliance with ISO 13485, 21 CFR Part 820, ISO 14971 , and applicable global device and combination product requirements.
The Senior Director serves as the Management Representative for the Device QMS , providing leadership for QMS effectiveness, regulatory compliance, management review, inspection readiness, and continual improvement. The role partners with senior Quality and business leaders on enterprise Quality initiatives .
Key Duties and Responsibilities:
• Define and execute the Device Operational QA strategy aligned with business, portfolio, and product priorities.
• Provide Quality oversight of CDMOs, suppliers, testing laboratories, and other external partners , including quality agreements, audits, performance, and risk management.
• Provide Quality oversight of internal design control, design transfer, manufacturing, testing, and product realization activities .
• Serve as Management Representative for the Device QMS, ensuring QMS effectiveness, management review, compliance, and continual improvement.
• Ensure compliance with ISO 13485, 21 CFR Part 820, ISO 14971 , and applicable global regulatory requirements.
• Provide strategic oversight of deviations, investigations, CAPA, change control, complaints, supplier quality, audits, and inspection readiness .
• Establish and monitor Quality metrics, risks, trends, and performance , driving timely escalation and resolution of significant issues.
• Provide Quality leadership for regulatory inspections, notified body audits, product milestones, and launch readiness .
• Partner with senior leaders on enterprise-wide Quality initiatives that improve compliance, operational effectiveness, and business performance.
• Build organizational capability through talent development, coaching, and strong cross-functional leadership .
Knowledge and Skills:
• Broad expertise in Device and Combination Product Quality Assurance, QMS, and operational Quality oversight .
• Strong knowledge of ISO 13485, 21 CFR Part 820, ISO 14971 , and applicable global regulatory requirements.
• Demonstrated experience with CDMO/external partner oversight, supplier Quality, testing, audits, and inspection readiness .
• Strong understanding of design controls, design transfer, risk management, manufacturing controls, supplier controls, and product realization .
• Proven experience with CAPA, investigations, deviations, change control, complaints, and quality risk management .
• Demonstrated capability to serve as Management Representative , including QMS performance, management review, compliance oversight, and risk escalation.
• Strong strategic thinking, business acumen, risk-based decision-making, and problem-solving skills.
• Ability to influence senior leaders and drive outcomes in a complex, matrixed organization .
• Demonstrated leadership in cross-functional strategic initiatives .
• Strong people leadership skills with demonstrated ability to develop talent, build organizational capability, and foster Quality ownership .
Education and Experience:
Bachelors degree in a scientific, allied health, or operations research field
Typically requires 15 years of relevant work experience and 5 years of supervisory/management experience or the equivalent combination of education and experience
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