Supervisor, Quality Assurance Internal Operations
Core
Lead QA Associates to ensure cGMP compliance in the manufacturing of clinical and commercial drug products, overseeing quality systems, investigations, and real-time manufacturing support.
Role type
Senior IC Quality Assurance Supervisor (Biopharma Manufacturing)
Builds
Clinical and commercial drug products
Domain
Biopharmaceuticals / cGMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, Quality System Events (QSE) management, manufacturing area line clearances, AQL sampling and inspection, Standard Operating Procedures (SOP) writing, CAPA and Quality Investigations, raw material release, regulatory audit support, aseptic gowning oversight, change control, quality metrics maintenance
Preferred skills
Manufacturing support experience, supervisory experience, GMP quality systems in pharma/biotech/medical device environment
Technologies
Microsoft Office, Windows
Responsibilities
Provide QA support for cGMP manufacturing operations; Coordinate cross-functional teams for procedure improvements; Oversee Quality System Events; Lead Associates in floor oversight; Supervise Quality Assurance Department employees; Ensure employee training on aseptic gowning and facility flow; Review raw material records and QC data; Write and revise SOPs, specifications, and deviations; Support external client audits and regulatory inspections; Maintain quality metrics.
Seniority
Senior, hands-on IC with supervisory duties