Senior Manager, Contamination Control and Sterility Assurance, RFM, QARA

This position reports to the Director, Global Contamination Control & Sterility Assurance and is part of the Global Quality Assurance & Regulatory Affairs (QARA) organisation, supporting the Filtration Business Unit. This position is located at any Cytiva manufacturing site including Pensacola, FL; Hauppauge, NY; Westborough, MA; Duncan, SC; and will be an on-site role.

What you will do

• Lead contamination control and sterility assurance programs across multiple manufacturing sites, ensuring alignment with Cytiva quality standards, business objectives, and regulatory requirements.
• Drive implementation and continuous improvement of contamination control strategies, microbial control programs, environmental monitoring programs, and sterility assurance practices across assigned sites.
• Serve as the technical subject matter expert for contamination control, sterility assurance, microbial control, sterilization, environmental monitoring, and aseptic processing.
• Provide technical leadership and support during regulatory inspections, customer audits, and internal quality assessments.
• Lead investigations, root cause analysis, quality risk assessments, and CAPA activities related to contamination events, environmental monitoring excursions, and sterility assurance issues.
• Establish, monitor, and drive performance through contamination control and sterility assurance metrics, trend analysis, risk management, and deployment of best practices across the manufacturing network.
• Act as the key liaison between global CCSA strategy and site execution, driving standardization, knowledge sharing, and sustainable business value creation across the manufacturing network.

Who you are

• Bachelor's degree in Microbiology, Biology, Pharmaceutical Sciences, Engineering, or a related scientific discipline.
• 10+ years experience within pharmaceutical, biotechnology, medical device, or other regulated life sciences manufacturing environments.
• Demonstrated expertise in contamination control, sterility assurance, aseptic processing, microbial control programs, environmental monitoring, contamination control strategy development, and contamination risk management.
• Experience supporting regulatory inspections, customer audits, investigations, CAPA programs, and quality risk management activities within regulated manufacturing environments.
• Experience leading technical teams, projects, or cross-functional initiatives in a global, multi-site environment.
• Strong knowledge of quality systems, contamination control principles, and regulatory compliance requirements applicable to regulated manufacturing operations.
• Proven ability to drive quality improvement, operational excellence, and microbiological risk reduction initiatives across manufacturing sites.

Travel, Motor Vehicle Record & Physical/Environment Requirements

Ability to travel approximately 20-30%, including domestic and international travel.

It would be a plus if you also possess previous experience in:

• Master's degree in Microbiology, Biology, Pharmaceutical Sciences, Engineering, or a related scientific discipline.
• Experience developing and implementing contamination control and sterility assurance programs across multiple manufacturing sites or global manufacturing networks.
• Expertise in sterilization technologies, including terminal sterilization, sterilization validation, ISO 11137, ISO 11737, contamination control strategy (CCS) principles, and environmental monitoring program governance.