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Senior Manager, Contamination Control, Sterility Assurance, QARA
Danaher Corporation. Lead contamination control and sterility assurance programs across multiple manufacturing sites .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in contamination control, sterility assurance, and microbial control within regulated manufacturing environments, with a strong focus on quality improvement and operational excellence. Proven ability to lead technical teams and drive the implementation of contamination control strategies across multiple sites.
Highest-signal resume keywords
Contamination ControlSterility AssuranceAseptic ProcessingRegulatory ComplianceQuality Risk Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Microbial Control ProgramsEnvironmental MonitoringContamination Control Strategy DevelopmentContamination Risk ManagementQuality Systems KnowledgeSterilization TechnologiesSterilization ValidationISO 11137ISO 11737CAPA Programs
Soft Skills
Technical LeadershipCross-Functional CollaborationRoot Cause AnalysisTrend AnalysisCommunication
Industry Keywords
Pharmaceutical ManufacturingBiotechnologyMedical DeviceRegulated Life SciencesQuality AssuranceGlobal Manufacturing Networks
About the role
Key responsibilities & impact- Lead contamination control and sterility assurance programs across multiple manufacturing sites
- Drive implementation and continuous improvement of contamination control strategies, microbial control programs, environmental monitoring programs, and sterility assurance practices
- 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
- 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
- Report to the Director, Global Contamination Control & Sterility Assurance, within the Global Quality Assurance & Regulatory Affairs organization, supporting the Filtration Business Unit
Requirements
What you’ll need- 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
- 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's degree in Microbiology, Biology, Pharmaceutical Sciences, Engineering, or a related scientific discipline (a plus)
- Experience developing and implementing contamination control and sterility assurance programs across multiple manufacturing sites or global manufacturing networks (a plus)
- Expertise in sterilization technologies, including terminal sterilization, sterilization validation, ISO 11137, ISO 11737, contamination control strategy (CCS) principles, and environmental monitoring program governance (a plus)
Benefits
Comp & perks- Bonus/incentive pay eligibility
- Paid time off
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)