Sr. Director, Compliance & Strategy, MQSA
Core
Define, maintain, and govern enterprise aseptic and microbial control frameworks, strategies, and regulatory compliance across a global manufacturing network.
Role type
Senior Director, Compliance & Strategy (Aseptic/Microbial Control)
Builds
Enterprise governance frameworks, contamination control strategies, and regulatory readiness programs for sterile and aseptic manufacturing.
Domain
Pharmaceutical manufacturing (small molecule, biologics, cell/gene therapy) and regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Aseptic processing expertise, Contamination control, Microbial quality assurance, Sterility assurance, Global regulatory interpretation, CMO/CDMO governance, Enterprise strategy, Change management, Risk assessment, Inspection readiness
Preferred skills
Advanced degree in Microbiology or related field, Experience with emerging aseptic technologies
Technologies
None explicitly listed
Responsibilities
Own and maintain enterprise CCS/SA governance frameworks and standards; Define and execute the enterprise aseptic and microbial control roadmap; Lead regulatory intelligence and engagement with health authorities; Support inspection readiness and provide technical compliance support; Govern CMO/CDMO aseptic practices and quality agreements; Develop global aseptic training and competency programs; Represent the company in industry consortia and benchmarking initiatives.
Seniority
Director, enterprise-level strategy & leadership
