Sr Director, Microbiology

About this role

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.   Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.   We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description   Key Responsibilities:

Enterprise Strategy & Governance     ●        Establish and execute the enterprise microbiology  and sterility assurance strategy aligned with corporate quality , manufacturing, and business objectives. ●        Develop and maintain the global governance framework   for microbiology, contamination control, and sterility assurance programs across all manufacturing sites and external manufacturing partners.       ●        Define global microbiological and sterility assurance standards, technical policies, procedures, and best practices to ensure consistent implementation throughout the organization. ●        Serve as the executive subject matter expert and advisor to senior leadership on microbiological risk, contamination control, sterility assurance, and emerging regulatory expectations.       . ●        Drive enterprise initiatives focused on operational excellence, scientific innovation, and digital transformation within microbiology laboratories and contamination control programs.           

Sterility Assurance & Contamination Control ● Provide strategic oversight of enterprise Contamination C ontrol S trategies (CCS) in accordance with EU GMP Annex 1 and global regulatory expectations. Establish scientific standards governing: o   Aseptic processing o   Sterile manufacturing o   Non-sterile manufacturing o   Biologics and biotechnology processes o   Cell and gene therapy operations o   Medical device and combination product manufacturing o   Water systems and clean utilities o   Facility cleaning and disinfection o   Sterilization technologies ●   Provide technical oversight for cleanroom design, classification, qualification, airflow visualization, HVAC systems, personnel qualification, gowning programs, material and personnel flows, and facility contamination prevention. ●   Ensure robust      environmental monitoring, utility monitoring,       aseptic process simulation (media fill), and contamination control programs are scientifically justified, risk-based, and global harmonized.                                                                                       ●   Lead enterprise microbial risk assessments       and contamination investigations for critical manufacturing events.

Laboratory & Technical Oversight

● Provide strategic oversight of enterprise microbiology laboratory operations, including: o   Environmental M onitoring o   Sterility Testing     o   Bioburden Testing     o   Bacterial Endotoxin Testing     o   Microbial Identification     o   Mycoplasma Testing     o   Antimicrobial E ffectiveness Testing o   Rapid Microbiological Methods o   Method Validation and Verification o   Microbiological Method Lifecycle Management     ●   Ensure laboratories programs maintain the highest standards of scientific integrity,       data integrity, and regulatory compliance while promoting innovation through automation, advanced analytics, and emerging technologies.                 .

Quality Systems & Regulatory Compliance

● Ensure enterprise microbiology programs remain compliant       with applicable FDA, EMA, MHRA, WHO, PIC/S, ICH, ISO, USP, EP, and other global regulatory requirements      . ●  Provide executive oversight for       microbiology-related deviations, investigations, CAPAs, change controls, quality risk assessments, validation stra tegies, and technical justifications. ● Represent the organization during regulatory inspections, customer audits, due diligence activities, and health authority inspections. Provide microbiological expertise supporting regulatory submissions, product filings, responses to regulatory agencies, and post-marke t commitments.           ●   Monitor evolving r egulatory expectations and best practices, proactively implementing improv ements across the enterprise.     

Investigation & Risk Management ● Lead scientific evaluation of significant microbiological events, contamination investigations, environmental monitoring excursions, sterility and aseptic processing simulation failures, utility excursions, and product impact assessments.                           ● Apply advanced scien tific principles and quality risk management methodologies to determine root cause , product impact and appropriate corrective actions. ● Establish enterprise microbial trending strategies utilizing statistical analysis and predictive analytics to identify emerging risks before product quality is impacted. ● Promote science-based decision making throughout the organization.                   Cross-Functional Collaboration ●Collaborate with       Global Manufacturing, Quality Operations, Facilities, Engineering, Validation, Technical Development, Supply Chain, Procurement, and Regulatory Affairs to:   o   Support facility design and expansion projects o   Guide technology transfers o

Similar jobs

• Associate Director, QC Microbiology — KBI · NC, Durham, National Way
• Senior Analyst, QC Microbiology — Resilience · West Chester, OH
• Scientist/Senior Scientist, Microbiology — Fieldstonebio · Woburn, MA
• Associate Scientist, Microbiology — Pfizer · Missouri, St. Louis, Chesterfield, United States
• Associate Scientist, Microbiology — Pfizer (Internaljobs) · Missouri, St. Louis, Chesterfield, United States
• Associate Scientist (Microbiology) — Fresenius Kabi · Wilson, NC
• Supervisor, Microbiology Quality Control — Biotechne · Minneapolis, MN
• Sr Associate I, Quality Control Microbiology — Biibhr · Research Triangle Park, NC