Director, Sterility Assurance

Key Responsibilities

Global Sterility Assurance Leadership

• Develop, implement, and continuously improve biological contamination control strategies addressing viral, bacterial, fungal, mycoplasma, endotoxin, and other adventitious agent risks.
• Drive and oversee the global sterility assurance strategy, including risk assessment, mitigation planning, gap closure, and sustainable implementation across manufacturing sites.
• Serve as a global subject matter expert and strategic leader for contamination control and aseptic manufacturing practices.

Risk Management and Site Support

• Lead global sterility assurance risk assessments and support sites in responding to contamination events, sterility failures, microbiological excursions, and adverse trends.
• Facilitate root cause investigations and implement effective corrective and preventive actions (CAPAs) across the network.
• Promote cross-site collaboration, knowledge sharing, and implementation of best practices.

Network Standardization and Continuous Improvement

• Drive harmonization of sterility assurance standards and contamination control programs across global sites.
• Establish and improve procedures governing facility and equipment design, process design, material transfer, environmental monitoring, microbiological testing, maintenance, cleaning, disinfection, and segregation controls.
• Champion continuous improvement initiatives that strengthen contamination control, consistency, and inspection readiness.

New Product Introduction and Technical Expertise

• Act as the global sterility assurance expert for product development, technology transfer, and new product introductions.
• Ensure phase-appropriate sterility assurance practices are embedded throughout development and commercial manufacturing programs.
• Support network expansion projects and new facility start-ups as required.

Capability Building and Regulatory Support

• Coach and train employees to strengthen understanding of biological risks, contamination control, and aseptic behaviors.
• Support regulatory inspections, customer audits, GQC audits, mock pre-approval inspections, due diligence activities, and other compliance initiatives as a sterility assurance SME.
• Monitor evolving industry and regulatory expectations and ensure timely implementation across the network.

What You'll Bring

Education

• Bachelor's, Master's, or higher degree in Microbiology, Pharmaceutical Sciences, Life Sciences, Biotechnology, Engineering, or a related scientific discipline.
• Advanced scientific qualifications or certifications are advantageous.

Experience

• Significant leadership experience within sterile pharmaceutical, biotechnology, biologics, cell and gene therapy, or related GMP-regulated environments.
• Deep expertise in sterility assurance, contamination control, microbiology, aseptic processing, and quality risk management.
• Demonstrated experience supporting complex investigations, contamination events, and regulatory inspections.
• Proven success influencing and leading within global, matrixed organizations.

Skills

• Expert knowledge of sterile manufacturing regulations and industry standards.
• Strong understanding of contamination control strategies and microbiological risk assessment.
• Excellent communication, coaching, and stakeholder management skills.
• Ability to drive global alignment while balancing site-specific operational needs.
• Continuous improvement mindset with a passion for scientific excellence and operational effectiveness.