Director, Product Quality Lead (PQL), Global Quality
Core
Lead product quality strategy and compliance for pharmaceutical products from clinical development through commercialization, serving as the single point of contact for product quality and acting as a product expert for CMC and manufacturing teams.
Role type
Director, Product Quality Lead (PQL)
Builds
Pharmaceutical therapies (HIV, viral hepatitis, COVID-19, cancer) for global markets
Domain
Life Sciences / Pharmaceutical Manufacturing / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP principles, science- and risk-based approaches, drug substance and drug product development, regulatory health authority submissions, inspection readiness, lifecycle management, control strategy development, comparability assessments, Annual Product Quality Reviews (APQRs), product quality risk assessments
Preferred skills
BLA/MAA/IND authoring and review, non-conformance investigations, technology transfer, parenteral and oral solid dosage form expertise, biologics experience
Technologies
GMP, ICH, EP, JP, USP, 21 CFR, PAI/PLI, IND, NDA, BLA, MAA
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, assess product quality impact for changes and deviations, ensure inspection readiness, support new product launches, act as delegate to Commercial Product Quality Head
Seniority
Director, strategic leadership and cross-functional influence
