Senior Manager, Quality (Sterility Assurance)

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

Position 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 required.
• Contribute to inspection readiness programs by mentoring coaching and challenging site based SMEs in CCME topics.
• Review of inspection/audit observation responses

Leadership and Culture

• Training and Personnel Qualification: Develop and deliver training programs on sterility assurance aseptic practices gowning microbiology and contamination control.
• Process ownership of assigned quality system elements such as APS EM Cleaning and Disinfection or others as applicable.
• Build and maintain strong relationships and collaborate effectively with all levels cross functionally within the organization. Facilitate continuous improvement and development of pragmatic compliant solutions to identified issues.
• Promote a culture of contamination control awareness and quality excellence and use data trending (EM utilities deviations) to drive improvements in aseptic control.
• Benchmark best industry practice through networking and attendance at key webinars seminars etc.

• Role model the 4-I corporate values of Integrity Intensity Innovation and Involvement.
  • Intensity Honor commitments communicate openly and demonstrate the highest ethical standards
  • Intensity Be determined to deliver results with speed excellence and a passion to succeed
  • Innovation Create value by transforming knowledge and ideas into differentiated products and services for our customers
  • Involvement Make connections to work as one global team embracing unique perspectives and treating others with dignity and respect

Required Qualifications:

• Bachelors or advanced degree in Microbiology Pharmaceutical Sciences Biotech or a related field.
• 510 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 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