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
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
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