Job Description
**Senior Manager, Sterility & Microbiology** **Lead a team of microbiologists to ensure completion of microbiological and bio-analytical testing, while managing sterilization controls and ensuring product quality requirements are met.** The Senior Manager, Sterilization & Microbiology will lead a team of microbiologists to ensure completion of all microbiological and bio-analytical testing. This includes special project/protocol testing in a timely and appropriate manner for all assigned sites. The successful candidate will be responsible for managing the Sterilization Controls Subsystem related activities for all assigned sites, partnering with Site/Divisional Business Quality Leads to ensure all local related quality metrics are met, and managing the Sterility Assurance teams for all assigned sites to ensure compliance with all quality and regulatory standards. **Key Responsibilities:** • Ensure product disposition plan attainment and that all products released meet the pre-determined quality requirements for all assigned sites. • Manage the Sterilization Controls Subsystem related activities for all assigned sites. • Partner with Site/Divisional Business Quality Leads to ensure all local related quality metrics are met. • Manage the Sterility Assurance teams for all assigned sites to ensure compliance with all quality and regulatory standards. • Assist in the implementation of quality and regulatory requirements (FDA, EU, GLP, and guidelines) and ensure compliance with testing SOP and specifications. • Monitor the testing techniques and accuracy of all records and documentation in the microbiology laboratory. • Initiate proactive functions to impact production, increase efficiency in the micro lab, solve problems generated during sterilization validation, and improve new product support in ECA and micro testing. • Evaluate performance via performance appraisal and ensure employee development plans are discussed as part of the annual performance review. • Conduct at least quarterly group meetings with the entire Sterility Assurance, micro, and quarantine service units to discuss future challenges. • Ensure all documentation is prepared, reviewed, and revised as required, including sterilization protocols, ECA excursions, micro investigations, TI, and specifications. • Establish environmental objectives and targets for continuous improvement across all assigned sites. • Combine regulatory guidelines with actual test results and practices to create knowledge for advancing quality improvement initiatives. • Supervise the Sterility Assurance Advisor and the Microbiology Laboratory and Product Disposition personnel for all assigned sites. • Coach and develop direct report subordinates. • Ensure inter-departmental compliance with company policies and corrective actions for all assigned sites. **Qualification Requirements:** • Bachelor's degree in science, Microbiology, or biological science preferred. • Master's degree desirable. • 10+ years of experience in a microbiology lab in medical device or pharmaceutical fields. • ISO Lead Auditor training is desirable. • Certified Quality Engineer (ASQ) is desirable.