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

Danaher Corporation•Westborough, MA

1d•$110,000 - $125,000•Onsite

About The Position

The Senior Manager, Contamination Control & Sterility Assurance (CCSA) is responsible for providing strategic leadership and technical expertise in contamination control, sterility assurance, microbial control, sterilisation, and aseptic processing across multiple Cytiva manufacturing sites. This role drives the development, deployment, and continuous improvement of contamination control strategies and sterility assurance programs that ensure regulatory compliance, audit readiness, operational excellence, and strong quality performance across the manufacturing network while supporting product quality, patient safety, and customer satisfaction. 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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.