Sr. Director, Aseptic Operational Support

Role: Senior Director leading enterprise aseptic and microbial control practices, with a focus on sterility assurance across global manufacturing sites. Responsibilities: govern aseptic policies, standards, and contamination risk escalation; define and monitor KPIs; drive cross-site harmonization through knowledge management and communities of practice; serve as technical authority for contamination events, technology transfers, and regulatory inspections; oversee environmental monitoring programs; and provide guidance on facility design, personnel flow, gowning, and CMO oversight. Qualifications: Bachelor's in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or related field; 15+ years in microbiology, sterility assurance, or contamination control; 8–10 years in senior leadership roles with enterprise accountability; extensive experience in biologics, cell or gene therapy manufacturing; deep knowledge of global regulatory frameworks (FDA, EMA, ICH, USP, etc.); proven track record in regulatory inspections and enterprise change management. Preferred: M.S. or Ph.D. in Microbiology or related field. High-Value: expertise in aseptic sciences, contamination control, environmental monitoring, and sterile manufacturing across complex modalities including biologics, cell, or gene therapies; senior leadership in quality or compliance; significant experience supporting regulatory interactions and CMO oversight. Work setup: Not specified but involves global enterprise leadership and cross-functional collaboration.