Manager, Quality Control
Core
Oversees analytical functions including testing, reporting, and stability samples for in-process, release, and stability samples across manufacturing centers.
Role type
Manager, Quality Control (Laboratory)
Builds
cGMP compliant testing and reporting processes for pharmaceutical/biopharmaceutical products
Domain
Biopharmaceuticals / Quality Control / Laboratory Operations
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
cGMP/GDP compliance, analytical methodologies (flow cytometry, cell counts, sterility, endotoxin, cell culture), OOS/OOT investigation, SOP authoring, team leadership, regulatory inspection experience
Preferred skills
None stated
Technologies
NC-200, BACT
Responsibilities
Manage laboratory programs and processes, coordinate lab activities to meet timelines, ensure personnel training, troubleshoot analytical methods/equipment, author and approve data and SOPs, monitor lab metrics, lead continuous improvement sub-teams, lead OOS/OOT investigations, coach and develop reports, serve as QC representative in cross-functional teams
Seniority
Manager, people management
