Executive Director, Microbiology Quality Sterility Assurance
Core
Global leadership role defining and governing the enterprise-wide Contamination Control Strategy (CCS) and sterility assurance framework across pharmaceutical, biopharmaceutical, cell therapy, and radiopharmaceutical manufacturing sites.
Role type
Executive Director, Microbiology Quality Sterility Assurance
Builds
Global sterility assurance strategy, CMO contamination control roadmaps, and a center of excellence for CCS governance.
Domain
Pharmaceutical manufacturing, biopharmaceuticals, cell therapy, radiopharmaceuticals, regulatory compliance (EU GMP, FDA).
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Contamination control strategy governance, aseptic-by-design principles, global regulatory compliance (EU GMP Annex 1, FDA), CMO due diligence and management, cross-functional stakeholder influence, executive-level communication, team building and capability development, risk-based framework design, KPI definition and trend analysis.
Preferred skills
Advanced degree in Microbiology or Life Sciences, CMO partnership management experience, industry standard-setting activities (PDA, ISPE, PhRMA).
Technologies
Digital environmental monitoring tools, advanced analytics, data-driven risk assessment approaches.
Responsibilities
Define and drive global sterility assurance strategy; serve as SPOC for contamination control; embed aseptic assurance into product development; lead CMO CCS implementation and due diligence; provide technical oversight of microbiological controls; lead regulatory inspections and inspection readiness; build and lead a global sterility assurance team.
Seniority
Executive Director, global leadership
