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Senior Manager, Contamination Control and Sterility Assurance

Listing for: Regulatory Jobs
Full Time position Listed on 2026-11-04
Job specializations:
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist, Quality Engineering
Salary/Wage Range or Industry Benchmark: 110000 - 125000 USD Yearly USD 110000.00 125000.00 YEAR

Job Description & How to Apply Below

Senior Manager, Contamination Control & Sterility Assurance (CCSA)

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.
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'…

Position Requirements

10+ Years work experience
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