Senior Manager, Quality Assurance (GMP Operations)
Core
Provide Quality leadership and direct oversight of Manufacturing and Quality Control (QC) operations for a new biologics manufacturing facility and QC Laboratory.
Role type
Senior Manager, Quality Assurance (GMP Operations)
Builds
Single Use DS Biologics Manufacturing facility and QC Laboratory
Domain
Biopharmaceuticals / GMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP/GLP compliance, QA principles, international quality systems regulations, Computer System Validation (CSV), Six Sigma/DMAIC, Risk Management (HACCP/FMEA), regulatory agency interaction
Preferred skills
Six Sigma/DMAIC methodology, Risk Management tools (HACCP/FMEA), ASQ certification
Technologies
Electronic records and signature systems
Responsibilities
Manage batch record review and release activities, oversee external QC laboratories and method lifecycle activities, review laboratory investigations and CAPAs, manage quality control data for method validation, apply Quality Risk Management principles, author and approve controlled documents, participate in site inspection readiness and internal audits
Seniority
Senior, hands-on IC
