Associate Director Quality, Microbial Contamination Control
Core
Provide quality oversight and lead improvement initiatives for sterility assurance and contamination control across internal sites and external manufacturing network for sterile drug and biological products.
Role type
Senior IC quality leader (microbial contamination control)
Builds
Sterility assurance frameworks, contamination control strategies, aseptic processing operations
Domain
Pharmaceutical manufacturing (sterile drugs/biologicals)
Required skills
Microbiology, aseptic process knowledge, GMP compliance, regulatory requirements (CFR, EU GMP, EMA/FDA), environmental monitoring, aseptic process simulation, air flow visualization, disinfection validation, site event investigation, mentoring
Preferred skills
None stated
Technologies
None stated
Responsibilities
Develop and implement sterility assurance frameworks aligned with Annex I and global GMP guidelines; Lead contamination control initiatives to improve aseptic techniques and operational controls; Provide Quality and Compliance guidance for inspection readiness; Lead Contamination Control assessments for aseptic processing steps; Support Site regulatory inspections and self-inspection programs; Provide aseptic subject matter expertise for external manufacturing auditing; Assess the Quality System for regulatory compliance.
Seniority
Senior, hands-on IC