Director, Product Quality Leader, Biologics
Core
Lead product quality strategy, risk assessment, and lifecycle management for biologics development and commercial programs.
Role type
Senior Director, Product Quality (Biologics)
Builds
Biologics drug substances and drug products for patient use
Domain
Biopharmaceuticals / Biologics
Required skills
cGMP principles, science-based risk assessment, regulatory filing strategy, control strategy development, inspection readiness, cross-functional leadership, data trend analysis, change management, technology transfer support, regulatory agency communication
Preferred skills
BLA/MAA authoring experience, non-conformance investigation leadership, advanced science degree, 5+ years in regulated GMP environment
Technologies
ICH, EP, JP, USP, 21 CFR, PAI/PLI
Responsibilities
Provide quality leadership on cross-functional teams, drive product strategies through quality and scientific knowledge, lead Product Quality Team activities, manage product quality risk registers, monitor cross-functional data for trends, develop control strategies, review and approve regulatory filings, provide cross-functional guidance, assess product quality impact for changes, support technology transfer and new product launches, ensure inspection readiness, apply science-based evaluation to complex issues, communicate complex quality information to leadership and agencies.
Seniority
Director, strategic leadership with hands-on technical expertise