Sr Director, Microbiology

Job description

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 Control Strategies (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 Monitoring o Sterility Testing o Bioburden Testing o Bacterial Endotoxin Testing o Microbial Identification o Mycoplasma Testing o Antimicrobial Effectiveness 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 strategies, 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-market commitments. ● Monitor evolving regulatory expectations and best practices, proactively implementing improvements 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 scientific 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 Support new product introductions o Improve manufacturing robustness o Evaluate supplier microbiological controls o Optimize contamination prevention strategies across the product lifecycle Organizational Leadership● Lead a world-class global microbiology organization focused on scientific excellence, operational performance, and continuous improvement. ● Develop technical capability through mentorship, coaching, succession planning, training programs, and technical development. ● Foster a culture of quality, accountability, innovation, and inspection readiness throughout the organization. ● Lead matrixed global teams and influence technical decision making across multiple business units and manufacturing sites. Required Qualifications ● Bachelor’s degree with 14+ years of experience or PhD, MS, or equivalent advanced degree with 12+ years of experience in Microbiology, Molecular Biology, Biological Sciences, or related scientific discipline; Significant executive leadership experience desired. ● Minimum of 12+ years of progressive experience in pharmaceutical microbiology, sterility assurance, or contamination control within regulated pharmaceutical, biologics, biotechnology, or medical device environments. ● Extensive experience supporting global sterile manufacturing operations and aseptic processing . ● Demonstrated expertise in : o FDA, EMA, MHRA, WHO, and other global GMP regulations o EU GMP Annex 1 o USP microbiology chapters o ICH Quality Guidelines o ISO microbiological standards o Quality Risk Management (ICH Q9) o Pharmaceutical Quality Systems (ICH Q10) o Aseptic Processing o Contamination Control Strategy development ● Proven success leading regulatory inspections and executive interactions with global health authorities. . ● Demonstrated leadership with large, complex, global matrixed organizations. Preferred Qualifications ● Experience implementing Rapid Microbiological Methods (RMM) and microbiology labor