Senior Manager/Associate Director, Quality Control
Core
Lead Quality Control activities for clinical and commercial drug substance and drug product programs, ensuring compliance with ICH and cGMP requirements.
Role type
Senior Manager/Associate Director, Quality Control
Builds
Clinical and commercial drug substance and drug product programs
Domain
Biopharmaceuticals, Neuroscience, Small molecules
Required skills
Quality control testing, stability program management, master specifications, method validations, OOS/OOT investigations, batch release processes, quality management systems, CMC regulatory submissions, external laboratory management, audit participation
Preferred skills
FDA/EMA inspection readiness, international regulatory environment knowledge, team leadership
Technologies
ICH guidelines, cGMP, IND, NDA, CTA
Responsibilities
Review and manage analytical/non-analytical results for product release and stability; lead stability activities including trending and statistical evaluation; manage reference standard programs; manage master specifications for starting materials, API, and drug products; lead investigations for OOS/OOT results; manage review and approval workflows for validation protocols and test methods; lead quality control checks on CMC sections of regulatory submissions; collaborate with QA on internal release documents; ensure compliance with quality functions including deviations and CAPAs; oversee sample movement between external partners and CMOs.
Seniority
Senior Manager/Associate Director, management level