Sr Director, Microbiology

Key Responsibilities
- Establish and execute the enterprise microbiology and sterility assurance strategy aligned with corporate quality, manufacturing, and business objectives.
- Develop and maintain global governance for microbiology, contamination control, and sterility assurance across manufacturing sites and external partners.
- Define global standards, policies, procedures, and best practices for microbiological and sterility assurance.
- Serve as executive SME/advisor on microbiological risk, contamination control, sterility assurance, and emerging regulatory expectations.
- Drive enterprise initiatives for operational excellence, scientific innovation, and digital transformation within microbiology and contamination control programs.
- Provide strategic oversight of enterprise Contamination Control Strategies (CCS) aligned with EU GMP Annex 1.
- Establish scientific standards for aseptic processing, sterile/non-sterile manufacturing, biologics/biotech, cell & gene therapy, medical devices/combination products, water systems, facility cleaning/disinfection, and sterilization technologies.
- Provide technical oversight for cleanroom design/classification/qualification, airflow visualization, HVAC, personnel qualification/gowning, material/personnel flows, and facility contamination prevention.
- Ensure environmental/utility monitoring, media fills/aseptic simulations, and contamination control programs are risk-based and globally harmonized.
- Lead microbial risk assessments and contamination investigations for critical events.
- Provide strategic oversight of microbiology lab operations (EM, sterility, bioburden, endotoxin, identification, mycoplasma, antimicrobial effectiveness, RMM, validation/verification, lifecycle management).
- Ensure compliance with FDA, EMA, MHRA, WHO, PIC/S, ICH, ISO, USP, EP and other global requirements.
- Oversee microbiology deviations/investigations/CAPAs/change controls/quality risk assessments/validation strategies.
- Represent the organization in regulatory/customer audits; support submissions and post-market commitments.
- Lead scientific evaluation of events and apply quality risk management to determine root cause and corrective actions.
- Establish microbial trending strategies using statistical and predictive analytics.
- Collaborate cross-functionally (Manufacturing, Quality Ops, Facilities, Engineering, Validation, Tech Dev, Supply Chain, Procurement, Regulatory Affairs) on design/expansion, tech transfers, NPI, robustness, supplier controls, and lifecycle contamination prevention.
- Lead global organization; develop talent (mentorship/coaching/succession/training); foster quality/accountability/innovation and inspection readiness.

Required Qualifications
- Bachelor’s degree + 14+ years, or PhD/MS + 12+ years in Microbiology/Molecular Biology/Biological Sciences or related field; significant executive leadership experience desired.
- 12+ years progressive regulated experience in pharmaceutical microbiology, sterility assurance, or contamination control (pharma/biologics/biotech/medical devices).
- Extensive experience supporting global sterile manufacturing and aseptic processing.
- Demonstrated expertise in GMP regulations (FDA/EMA/MHRA/WHO and others), EU GMP Annex 1, USP microbiology chapters, ICH Quality Guidelines, ISO microbiological standards, ICH Q9/Q10, aseptic processing, and contamination control strategy development; success leading regulatory inspections and executive interactions.
- Demonstrated leadership in large, complex, global matrix organizations.

Preferred Qualifications
- RMM and microbiology lab automation.
- ATMPs/cell & gene therapy, vaccines, biologics, or combination products.
- Board/professional certification.
- Digital lab platforms, predictive analytics, data visualization tools.
- Lean/Six Sigma/Operational Excellence training.

Application Instructions
- For current employees/contractors: apply via the Internal Career Opportunities portal in Workday.