Senior Manager, Sterility Assurance

About the role

The Sr. Manager, Sterility Assurance is responsible for leading and advancing the site’s sterility assurance and microbiology programs to ensure compliance with applicable regulatory requirements and industry best practices for sterile radiopharmaceutical manufacturing.

Responsibilities

• Lead and mentor the Microbiology team, fostering a high-performance culture.
• Oversee and manage laboratory and environmental investigations, ensuring root causes are accurately identified and addressed.
• Conduct risk assessments and root cause analyses to resolve sterility assurance and microbiology issues.
• Develop and implement corrective and preventative actions (CAPAs) to mitigate identified issues.
• Provide microbiological expertise to support contamination control strategies and overall sterility assurance.
• Develop, document, and manage the site contamination control strategy.
• Design and implement training programs for cleanroom behavior and contamination control practices.
• Establish appropriate response plans to environmental events in clean rooms.
• Write, review, and revise relevant Standard Operating Procedures (SOPs) to support continuous improvement and regulatory compliance initiatives.
• Collaborate with cross-functional teams to support the validation and qualification of new equipment and microbiological methods.
• Perform additional job-related duties to meet organizational needs.
• Oversee the Environmental Monitoring (EM) program, including trending data, setting limits, and ensuring compliance with industry standards.
• Lead the site Contamination Control Strategy (CCS) in alignment with EU GMP Annex 1 expectations.
• Develop long-term sterility assurance strategies to support clinical and future commercial manufacturing operations.
• Serve as the site SME during regulatory inspections, client audits, and quality assessments related to microbiology and sterility assurance programs.
• Partner with Operations, Engineering, MSAT, and Validation to ensure microbiological considerations are incorporated into facility, equipment, utility, and process design.
• Provide microbiological risk assessments and quality oversight for new product introductions, technical transfers, and process changes.
• Lead microbiology and sterility assurance inspection readiness activities, including audit preparation, mock inspections, and remediation efforts.
• Ensure microbiology programs remain inspection-ready and compliant with FDA, EMA, and global regulatory expectations.
• Build, mentor, and develop a high-performing microbiology and sterility assurance organization focused on accountability, technical excellence, and continuous improvement.
• Establish performance metrics and KPIs to monitor microbiological control performance and drive continuous improvement initiatives.
• Oversee trending and statistical evaluation of environmental monitoring data to identify emerging risks and drive proactive mitigation strategies.
• Lead investigations associated with environmental monitoring excursions, sterility failures, and contamination events.
• Ensure robust microbiological support for deviations, CAPAs, change controls, investigations, and risk assessments.
• Support implementation and optimization of electronic quality systems (eQMS), LIMS, and data integrity practices related to microbiology operations.
• Ensure the qualification and validation of cleanroom facilities, HVAC systems, and critical utilities necessary for sterility assurance.
• Lead data-driven initiatives, using analytics to identify trends in microbiological or environmental data, and proactively address potential issues.
• Collaborate with cross-functional teams, including Regulatory Affairs, Engineering, and Production, to align sterility assurance strategies with overall manufacturing goals.
• Manage and qualify vendors and raw materials from a microbiological perspective to ensure compliance with sterility standards.

Qualifications & Requirements

• Bachelor’s degree in Life Sciences or related field is required.
• Minimum 8 years’ experience in sterility assurance, microbiology, or aseptic manufacturing within a GMP-regulated pharmaceutical or radiopharmaceutical environment required.
• Minimum 5 years of progressive leadership experience managing microbiology, sterility assurance, or contamination control programs required.
• Deep knowledge of FDA 21 CFR Parts 210, 211, and applicable EU GMP Annex 1 requirements.
• Experience supporting regulatory inspections and client audits required.
• Superior teamwork, multi-tasking, and time management skills.
• Excellent communications, interpersonal and collaboration skills, and ability to interact professionally with a wide range of individuals and organizations, internal and external.
• Extensive experience with aseptic processing, environmental monitoring, cleanroom qualification, contamination control strategies, and microbiological investigations required.
• Knowledge and ability to write, review, and revise Standard Operating Procedure (SOPs).
• Hands-on experience with aseptic processing and environmental monitoring in cleanroom environments.
• Ability to work in a cleanroom and sterile compounding environment, adhering to strict health and hygiene standards to ensure the safety and quality of drug products.
• Must report any health conditions (e.g., rashes, active infections) that could impact product integrity or contamination risks.
• Chronic health conditions that prevent long-term performance of essential job functions may require evaluation and could affect employment status.
• Proper garbing and personal hygiene must be maintained at all times when in the cleanroom or compounding areas.
• Experience supporting facility startup, commissioning, qualification, and validation activities preferred.
• Experience in startup, CDMO, or rapidly scaling GMP manufacturing environments strongly preferred.
• Familiarity with radiation safety protocols and the unique requirements of handling radiopharmaceuticals.