Executive Lead, Device Quality & QMS Strategy

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

Benefits offered by this job

Annual bonus

Equity awards

Hybrid/On-site flexibility

Generous PTO and benefits

Job summary

Vertex Pharmaceuticals is seeking a Senior Director of Device Quality to lead strategic quality oversight for device and combination product operations across development through post-market activities.

You will manage risk-based QA for internal activities and external partners, ensuring compliance with ISO 13485, 21 CFR Part 820, ISO 14971, and global requirements while driving continual improvement and regulatory readiness.

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 QA strategy aligned with priorities.
• Provide QA oversight of CDMOs, suppliers, testing labs, and external partners.
• Oversee internal design controls, design transfer, manufacturing, testing, and product realization.
• Serve as Management Representative for the Device QMS and ensure its effectiveness.
• Ensure compliance with ISO 13485, 21 CFR Part 820, ISO 14971 and global requirements.
• Lead deviations, investigations, CAPA, change control, and supplier quality.
• Establish and monitor quality metrics, risks, and performance with timely escalation.
• Provide QA leadership for regulatory inspections and launch readiness.
• Partner with senior leaders on enterprise-wide Quality initiatives.
• Develop talent and foster cross-functional Quality ownership.

Skills

Device Quality Assurance

Regulatory compliance

CDMO oversight

Risk management

Education

Bachelor's degree in science

Job description

Vertex Pharmaceuticals is seeking a Senior Director of Device Quality to lead strategic quality oversight for device and combination product operations across development through post-market activities.

You will manage risk-based QA for internal activities and external partners, ensuring compliance with ISO 13485, 21 CFR Part 820, ISO 14971, and global requirements while driving continual improvement and regulatory readiness.