Senior Manager, Contamination Control and Sterility Assurance
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering
Job Description & How to Apply Below
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career.
Learn about Danaher Business System which makes everything possible.
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.
- 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.
- Ability to travel approximately 20-30%, including domestic and international travel.
- Master'…
Position Requirements
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