Director, Product Quality Leader, Biologics
Core
Director-level Product Quality Leader ensuring end-to-end product quality, compliance, and lifecycle management for biologics from clinical development through commercialization.
Role type
Senior IC Director, Product Quality (Biologics)
Builds
Biologics therapies for patients with HIV, viral hepatitis, COVID-19, and cancer.
Domain
Biopharmaceuticals / Biologics / Regulatory Compliance
Required skills
cGMP principles, science- and risk-based approaches, control strategy development, regulatory filing support (IND/NDA/BLA), inspection readiness, cross-functional leadership, lifecycle management, comparability assessments, Annual Product Quality Reviews (APQRs), technology transfer.
Preferred skills
Advanced science degree (MS/PhD), 5+ years in regulated GMP environment, influence without authority, complex problem solving.
Technologies
GMP, ICH, EP, JP, USP, 21 CFR, PAI/PLI, APQR, JOS
Responsibilities
Define product Quality and Compliance strategy; lead Product Quality Team activities; drive identification and mitigation of product quality risks; review and approve regulatory filings; ensure inspection readiness; assess product quality impact for changes and deviations; support technology transfer and new product launches.
Seniority
Director, strategic leadership & hands-on technical execution