Senior GMP Quality Manager — Biologics & Devices

Vertex Pharmaceuticals; Seattle (WA); On-site; USD 243,560,000 - 257,887,000; Full time

Job summary

Vertex Pharmaceuticals in Seattle seeks a Sr. Quality Manager to drive QA and GMP compliance across biologics and devices. You will coordinate complex projects, lead CAPA programs, and ensure proper change controls with CMOs and Vertex.

Key responsibilities include investigations, root cause analysis, and risk mitigation, with hands-on review of master and executed batch records to support DS/DP/FG disposition. Strong cross-functional communication is essential.

Qualifications

• Bachelor's degree in a scientific or allied health field.
• Typically requires 8 years of experience in QA/GMP environments.

Responsibilities

• Collaborate with partners to resolve complex quality issues and ensure compliant solutions.
• Draft and enforce Quality Agreements with CMOs/Suppliers and Vertex as needed.
• Assist Change Control owners and assess change controls for compliance.
• Lead investigations/deviations with root cause analysis and CAPA.
• Review batch records for DS/DP/FG disposition activities.
• Support internal and external audit programs.

Skills

QA & GMP expertise

Quality leadership

Cross-functional collaboration

Risk management

Change control & CAPA

Audits and investigations

Education

Bachelor's degree in science or health

Tools

QDocs

TrackWise

Veeva

Job description

Vertex Pharmaceuticals in Seattle seeks a Sr. Quality Manager to drive QA and GMP compliance across biologics and devices. You will coordinate complex projects, lead CAPA programs, and ensure proper change controls with CMOs and Vertex.

Key responsibilities include investigations, root cause analysis, and risk mitigation, with hands-on review of master and executed batch records to support DS/DP/FG disposition. Strong cross-functional communication is essential.