Hiring: Director, Quality (Contamination Control and Microbial Excellence) Company: Thermo Fisher Scientific Location: Greenville, NC Job Posted Time: 2026-09-13 07:40:48 About the job Experience: •10 years experience in supporting sterile/low bioburden pharmaceutical manufacturing and/or microbiology roles. Required Skills: •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. •Support digitalization and innovation across PSG sites Qualifications: •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. •In-depth knowledge 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. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!