Associate Director, Aseptic Operational Support
Core
Provide authoritative technical input on facility and utility design standards, risk assessments, and quality impact assessments to ensure sterility assurance and microbial control in aseptic manufacturing environments.
Role type
Senior IC Quality SME (Aseptic Facility & Utilities)
Builds
Enterprise-level quality standards, design packages, and contamination control strategies for sterile facilities and utilities.
Domain
Pharmaceutical manufacturing / Aseptic processing / Quality Assurance
Required skills
Aseptic processing expertise, Contamination Control Strategy (CCS) development, Risk assessment (FMEA, HACCP), Regulatory inspection defense, Sterilization validation, Single-use technology qualification, Cleanroom design standards, Microbial risk assessment
Preferred skills
M.S. in Microbiology or Pharmaceutical Sciences, Experience with ExM partners (CMOs/CDMOs), Advanced airflow visualization techniques
Technologies
EU GMP Annex 1, FDA Aseptic Processing Guidance, ISO 14644, ISO 11135/11137, USP <1116>, PDA Technical Reports, RABS, Isolators, WFI, HVAC systems
Responsibilities
Review and approve global risk assessments and quality impact assessments for contamination events; Lead high-complexity Business Technical Assessments (BTAs) for regulatory submissions; Serve as Global Quality SME for aseptic facility design and utility qualification; Define enterprise-level quality standards for cleanroom classification and airflow; Own development of sterilization design standards and bioburden control strategies; Provide oversight of aseptic design at external manufacturing partners.
Seniority
Senior, hands-on IC with leadership responsibilities