Director, Quality (Contamination Control and Microbial Excellence)

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

The Director, Quality (Contamination Control and Microbial Excellence) at Thermofisher plays a critical role in ensuring that all GMP operations maintain the highest standards of contamination control, sterility assurance and microbiological excellence. This position is a collaborative role, working with fellow CCME team members, Operations, MSAT, Engineering and quality colleagues.

The role is responsible for the definition and implementation of global policies and standards related to contamination control, sterility assurance and microbiology across all PSG sites to ensure alignment, standardization and compliance with current regulatory requirements.

ROLE AND RESPONSIBILITIES:

• 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:

• Bachelor’s or advanced degree in Microbiology, Pharmaceutical Sciences, Biotech, or a related field.
• 8–10 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