Senior Director, Device Quality & Compliance Leader

Vertex Pharmaceuticals; Boston (MA); Hybrid; USD 214,000 - 320,000; Full time

Benefits offered by this job

Hybrid-Eligible / On-Site Eligible

Job summary

Vertex is seeking a Senior Director, Device Quality to provide strategic quality leadership across development, manufacturing, testing, clinical, and post-market activities. You will own risk-based oversight of internal activities and external partners, ensuring compliance with global device requirements.

The role serves as the Management Representative for the Device QMS, guiding QMS effectiveness, regulatory readiness, and continual improvement.

Qualifications

• Broad expertise in Device and Combination Product Quality Assurance and QMS.
• Strong knowledge of ISO 13485, 21 CFR Part 820, ISO 14971.
• 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.

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.

Skills

Device QA leadership

QMS oversight

Regulatory compliance

Cross-functional leadership

Risk-based decision-making

Quality metrics

Strategic thinking

Management Representative

Education

Bachelor's degree in a scientific field

Job description

Vertex is seeking a Senior Director, Device Quality to provide strategic quality leadership across development, manufacturing, testing, clinical, and post-market activities. You will own risk-based oversight of internal activities and external partners, ensuring compliance with global device requirements.

The role serves as the Management Representative for the Device QMS, guiding QMS effectiveness, regulatory readiness, and continual improvement.