Manager, Quality Control
Core
Oversees daily quality control operations for chemical, biopharmaceutical, and microbiologic testing services, including raw material, in-process, and product release testing.
Role type
Manager, Quality Control (cGMP)
Builds
Quality testing services and regulatory compliance reports for biopharma clients
Domain
Biopharmaceuticals / cGMP Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, deviation/OOS investigation management, team leadership (5+ people), cross-functional process harmonization, regulatory reporting, risk assessment, technical troubleshooting
Preferred skills
CMO experience, process improvement, mentoring, problem-solving
Technologies
cGMP, FDA/EMA/ICH regulations
Responsibilities
Provide QC oversight of all cGMP testing (raw materials, in-process, product release, environmental monitoring); Review and approve QC investigations (deviations, OOS/OOT); Manage and develop department staff; Interface with clients and suppliers on quality issues; Conduct risk assessments and drive operational improvements; Support regulatory information requests
Seniority
Manager, hands-on leadership