Senior Director, GMP Quality
Core
Build and maintain fit-for-purpose GMP quality systems and provide independent oversight of CDMOs, contract labs, and strategic partners to ensure regulatory compliance for biologics development and commercialization.
Role type
Senior Director, GMP Quality (Hands-on IC leadership)
Builds
Biologics development programs from preclinical through commercialization
Domain
Biopharmaceuticals / Biologics / GxP Quality
Deliverable
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP/GLP quality leadership, biologics development oversight, CMC/QC strategy, CDMO management, regulatory submission support, risk management, data integrity, audit readiness, change control, CAPA management, technology transfer, process validation, stability testing, comparability assessment
Preferred skills
Pre-approval inspection experience, virtual biotech operating models, quality automation tools, combination product development
Technologies
Electronic systems, automation, data-driven quality tools
Responsibilities
Establish scalable risk-based GxP frameworks; oversee CMC and analytical strategies; lead CDMO relationships and audits; approve GMP documentation and batch releases; drive quality risk management and inspection readiness; support regulatory submissions and health authority interactions; mentor quality teams
Seniority
Senior Director, strategic leadership with hands-on operational involvement