QA Sterility Assurance Manager 80-100%
Core
Lead sterility assurance, contamination control, and quality excellence for sterile manufacturing to safeguard patient safety.
Role type
Senior IC sterility assurance manager
Builds
Sterile medicines and therapies
Domain
Life sciences / Pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
EU GMP Annex 1 expertise, Contamination Control Strategy (CCS) development, aseptic processing, media fills (APS), contamination risk management, root cause analysis, regulatory inspection readiness
Preferred skills
German language proficiency, audit experience
Technologies
None stated
Responsibilities
Lead sterility assurance strategy and CCS enhancement; support facility design, qualification, validation, and technology transfers; champion quality culture via risk assessments and training; represent QA during inspections and audits
Seniority
Senior, hands-on IC