Senior Manager, Quality – CCME
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Ireland
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Job Level
About the role
- Assist site-based CCME colleagues in development of site contamination control strategies, aligned with global quality procedures and EU GMP Annex 1, FDA 21 CFR, ISO, and PIC/S.
- Provide subject matter expertise (SME) in microbiology, microbiological methods, contamination control, aseptic processing, Environmental Monitoring, cleanroom design, and other relevant areas required by site CCME teams.
- Global review of EM trends from the PSG network and support site teams in remediation of adverse trends to maintain aseptic control.
- Promote contamination control awareness through data trending to drive improvements.
- Lead/support complex deviation or laboratory investigations and where appropriate, support CAPA plan definition and continuous improvement initiatives.
- Lead/support complex CCME related risk assessments.
- Ensure all GMP operations align with global regulatory requirements (FDA, EMA, MHRA, WHO, etc.).
- Mentor site based CCME SME’s prior to and during regulatory inspections, client and internal audits.
Requirements
- Minimum of BSc. in science related field, preferably Microbiology or Biological Sciences.
- >10 years experience working in a GMP environment with direct experience of operational support, contamination control and Microbiology testing.
Benefits
- Health insurance
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
microbiologymicrobiological methodscontamination controlaseptic processingEnvironmental Monitoringcleanroom designGMP operationsCAPA plan definitionrisk assessmentsdata trending
Soft Skills
subject matter expertisementoringleadershipcommunicationcollaborationproblem-solvingcontinuous improvement
Certifications
BSc in scienceMicrobiologyBiological Sciences