QA Sterility Assurance Lead, Visp e/v/e/r/y/o/n/e
Core
Lead contamination control strategy and sterility assurance for GMP-regulated sterile manufacturing operations, ensuring product quality and regulatory compliance.
Role type
Senior IC Sterility Assurance & Contamination Control Lead
Builds
Sterile injectable treatments for patients
Domain
Pharmaceutical manufacturing / Sterile processing
Required skills
GMP sterile manufacturing expertise, Contamination Control Strategy (CCS) design, cleanroom design and qualification, regulatory remediation, sterility investigation leadership, aseptic operator qualification, cross-functional risk assessment, data trending analysis, regulatory inspection management
Preferred skills
Advanced therapy product experience, aseptic facility build expertise, utility-based contamination resolution
Technologies
HVAC zoning, RABS, isolators, EM programs
Responsibilities
Design and implement site-wide Contamination Control Strategies aligned with EU GMP Annex 1, lead sterility assurance investigations (environmental/product contamination, media fill excursions), manage regulatory remediation and requalification, oversee aseptic operator qualification and personnel monitoring, assess trending data to drive preventive actions, prepare for regulatory inspections and client audits
Seniority
Senior, hands-on IC