Senior GMP Quality Leader — Biologics & Devices

Vertex Pharmaceuticals Inc (US)

Boston (MA)

Hybrid

USD 95,000 - 142,000

Full time

2 days ago

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Job summary

Vertex Pharmaceuticals is seeking an Associate Director, GMP Operational Quality Assurance to lead strategic and operational QA across programs. You will oversee deviations, CAPA, investigations, and QA oversight for external drug substance disposition, ensuring patient safety and regulatory compliance.

Collaborate with Product Quality Leads, MSAT, Regulatory Affairs, CDMOs, and suppliers to align quality decisions.

Qualifications

Bachelor's degree required with 8+ years GMP Quality experience and leadership.
Proven ability to lead complex quality initiatives with external manufacturing.
Experience with quality systems in a biologics setting.

Responsibilities

Lead cross-functional collaboration to resolve deviations and ensure compliance.
Represent Quality on teams as senior technical resource and decision-maker.
Negotiate and oversee Quality Agreements with CDMOs and suppliers.
Provide QA direction to Change Control owners for regulatory alignment.
Approve investigations, CAPAs, and root cause analyses.
Review batch records and support external drug substance disposition.
Analyze Quality Metrics to drive continuous improvement.
Prepare for IND/IMPD, PPQ, and regulatory inspections.