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 laboratory automation.
• Experience supporting, ATMPs, cell and gene therapy, vaccines, biologics, or combination products.
• Board certification or professional certification through recognized microbiology or quality organizations.
• Experience implementing digital laboratory platforms, predictive analytics, and data visualization tools.
• Lean, Six Sigma, Operational Excellence, or equivalent continuous improvement training .

Critical Competencies
• Executive leadership and influence
• Scientific and technical expertise
• Strategic vision
• Risk-based decision making
• Enterprise influence
• Business acumen
• Investigation and problem-solving capability
• Regulatory inspection readiness
• Change leadership
• Cross-functional collaboration
• Talent development and coaching
• Executive communication
• Innovation and digital transformation

The salary range for this position is: $221,000.00 - $286,000.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.