QC Manager
Core
Oversight of GMP analytical testing performed by contract sites and internal GMP analytical laboratory operations.
Role type
Senior Quality Control Manager (Biopharmaceuticals)
Builds
Clinical and commercial drug products
Domain
Biopharmaceuticals / Neurological, psychiatric, endocrine, and immunological disorders
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, analytical testing oversight, method validation, stability data review, deviation investigation, change control, regulatory submissions, vendor audit management, root cause analysis, electronic document management
Preferred skills
Leadership of junior staff, cross-functional collaboration, problem-solving tools application
Technologies
Electronic document management systems, laboratory data management systems, document control systems
Responsibilities
Review and approve API and drug product analytical records; Review and approve stability data for retest periods; Lead or participate in deviation and laboratory investigation teams; Conduct audits of external vendors; Author and review analytical modules in regulatory submissions
Seniority
Senior, hands-on IC with leadership capabilities