Associate Director, GMP Operational Quality

The Associate Director, GMP Operational Quality Assurance leads day-to-day quality operations and provides strategic oversight for drug substance disposition from development through process performance qualification. This role acts as a senior technical resource to cross-functional teams, managing complex quality initiatives, risk mitigation, and compliance with regulatory expectations in a biologics pharmaceutical setting. The position involves leading investigations, approving change controls, and ensuring quality readiness for major development milestones and regulatory inspections.