Senior Manager, Quality (Sterility Assurance)

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards 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:

Summary: The Senior Manater, Quality (Sterility Assurance) 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 global team members, Operations, MSAT, Engineering and quality colleagues. The role is responsible for the definition and implementation of site sterility assurance policies and procedures, in alignment with 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. Core Roles and Responsibilities Site Support 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 sterility assurance, microbiology, microbiological methods, contamination control, aseptic processing, Environmental Monitoring, cleanroom design, cleaning and disinfection and other relevant areas required by site CCME and corporate quality management.   Support review of EM trends across the site and work with site teams to remediate adverse trends and maintain environmental control in all cleanrooms. Provide site support and direction to complex deviations 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 site support for complex risk assessments related to Microbiology, Contamination Control and Sterility Assurance. Own and implement the site APS strategy in alignment with the PSG APS strategy and collaborate with MSAT, validation and Operations to oversee compliant execution of each APS. Provide guidance and coaching to Quality on the Floor in all sterility assurance matters to ensure maintenance of contamination controls during all operational activities. Provide oversight and approval of Airflow Visualization studies and collaborate with MSAT, validation and operations in their execution. Support development and implementation of the site intervention risk assessment and aseptic intervention strategy. Provide guidance and support for training, coaching, oversight and monitoring of aseptic practices during all operational activities. Act as process owner and implementation lead for the implementation of all global CCME procedures. 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 Provide subject matter expertise during regulatory inspections and internal audits. Ensure all GMP operations comply with global regulatory requirements (FDA, EMA, MHRA, WHO, etc.). Participate in internal/corporate audits when