Director, Quality – Contamination Control, Microbial Excellence

Thermo Fisher Scientific

Director of Quality ensuring compliance with contamination control standards at Thermo Fisher. Leading global quality initiatives for microbiology and sterility assurance across multiple PSG sites.

Posted 6/3/2026full-timeRemote • Massachusetts, Montana, New Jersey, North Carolina, Ohio • 🇺🇸 United StatesLead💰 $145,500 - $218,250 per yearWebsite

About the role

Key responsibilities & impact

Support site based CCME colleagues to develop, implement, and maintain site contamination control strategies based on contamination control risk assessment in alignment 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, cleaning and disinfection and other relevant areas required by site CCME teams and corporate quality management
Support global review of EM trends from the PSG network and work with site teams to remediate adverse trends and maintain environmental control in all cleanrooms
Provide above-site support and direction to PSG sites for complex deviation or laboratory investigations related to Microbiology, Contamination Control and Sterility Assurance
Where appropriate, support with CAPA plan definition, preventive measures and continuous improvement initiatives
Provide above-site support and direction to PSG sites for complex risk assessments related to Microbiology, Contamination Control and Sterility Assurance
Provide guidance during facility and process design, including design led contamination controls and material/personnel and waste flows
Provide SME input into the qualification of manufacturing equipment and cleanroom that impact CCME including proper selection and validation of sterilization processes (e.g., autoclaves, SIP, filter integrity testing)
Inspection Readiness
Support digitalization and innovation across PSG sites

Requirements

What you’ll need

Bachelor’s or advanced degree in Microbiology, Pharmaceutical Sciences, Biotech, or a related field
5–10 years experience in supporting sterile/low bioburden pharmaceutical manufacturing and/or microbiology roles
Strong understanding of aseptic manufacturing, cleanroom classification, disinfection, and contamination control
Deep knowledge of GMP, Annex 1 (2022 revision), FDA aseptic guidance
Understanding of barrier technologies (RABS, isolators) and their implementation
Effective communicator, able to influence and collaborate with cross-functional teams
Prior experience with regulatory inspections and audit defense
Experience with CCS implementation preferred

Benefits

Comp & perks

A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

microbiologyaseptic processingEnvironmental Monitoringcleanroom designcleaning and disinfectionGMPAnnex 1FDA 21 CFRCAPAsterilization processes

Soft Skills

effective communicatorinfluencecollaboratecross-functional teamworksubject matter expertise