Director, GMP QA Operations

Role

Director of GMP QA Operations overseeing quality assurance for clinical and commercial products in an oncology-focused biopharma.

Responsibilities

• lead QA activities across external manufacturing, including Drug Substance, Drug Product, and Finished Product
• review batch records, deviations, investigations, and batch disposition
• ensure GMP compliance, inspection readiness, and quality risk management
• support regulatory filings, inspections, and lifecycle activities
• provide leadership and mentorship to QA teams

Requirements

• Bachelor's in a scientific/technical discipline
• 12+ years in GMP Quality, with 5+ years managerial experience
• extensive support of small molecule manufacturing, especially oral solid dosage forms
• strong knowledge of GMP regulations, batch release, and external partner oversight

Preferred

• experience with commercial batch disposition, global supply, and post-approval lifecycle

HighValue

GMP quality oversight for small molecule manufacturing, clinical to commercial phases, supporting external manufacturing networks, and regulatory compliance within oncology drug development.

WorkSetup

on-site in Redwood City, CA, with a salary range of $211,000-$264,000 USD.