Principal Product Quality Leader
Core
Provide technical expertise and leadership for late-stage and commercial biologics products, ensuring product health through GMP compliance, regulatory filings, and quality risk assessments.
Role type
Principal Product Quality Leader (Biologics)
Builds
Late-stage and commercial biologics medicines
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
cGMP knowledge, regulatory documentation authoring, scientific data management, cross-functional quality leadership, risk-based evaluation, comparability assessments, annual product reviews, stability program management, site and method transfers
Preferred skills
Advanced degree in chemistry/biochemistry/biology, 6+ years in regulated GMP environment with biologics, experience authoring market applications/INDs
Technologies
GMP systems, regulatory filing platforms
Responsibilities
Author and review GMP and regulatory documents; execute transactions in GMP systems; manage product data including comparability and annual reviews; lead cross-functional quality initiatives for product filings and investigations; support program deliverables for late phase and commercial programs; evaluate complex process and product quality data
Seniority
Principal, hands-on IC with strategic oversight