Senior Director, Device Quality & Compliance Leader

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

Job summary

Vertex Pharmaceuticals LLC seeks a Senior Director, Device Quality to lead risk-based quality oversight for device and combination products across development, manufacturing, testing, clinical, commercial and post-market activities. The leader ensures compliance with ISO 13485, 21 CFR Part 820, ISO 14971 and global requirements and serves as the Management Representative for the Device QMS.

The role partners with senior Quality and business leaders on enterprise initiatives, driving CAPA, change

Qualifications

• Bachelor's 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

Responsibilities

• Define and execute the Device Operational QA strategy aligned with business, portfolio, and product priorities.
• Provide Quality oversight of external partners including 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

Quality leadership

Regulatory compliance

QMS management

Cross-functional leadership

Education

Bachelor's degree in science/engineering

Job description

Vertex Pharmaceuticals LLC seeks a Senior Director, Device Quality to lead risk-based quality oversight for device and combination products across development, manufacturing, testing, clinical, commercial and post-market activities. The leader ensures compliance with ISO 13485, 21 CFR Part 820, ISO 14971 and global requirements and serves as the Management Representative for the Device QMS.

The role partners with senior Quality and business leaders on enterprise initiatives, driving CAPA, change