Job Description
Job TitleSenior Manager, Sterility & MicrobiologyReports ToSenior Director of Quality AssurancePosition SummaryThe Senior Manager, Sterilization & Microbiology will lead and develop a team of 4-7 microbiologists while ensuring completion of all microbiological and bio-analytical testing. You will be responsible for special project/protocol testing in a timely and appropriate manner for all assigned sites.Key Areas of ResponsibilityEnsuring product disposition plan attainment, and that all products released meet the pre-determined quality requirements for all assigned sites.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.Managing the Sterility Assurance teams for all assigned sites to ensure compliance with all quality and regulatory standards.Assisting during implementation of quality and regulatory requirements (FDA, EU, GLP, and guidelines) and ensuring compliance with testing SOP and specifications.Monitoring the testing techniques and accuracy of all records and documentation in the microbiology laboratory.Initiating pro-active 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.Evaluating performance via performance appraisal and ensuring employee development plans are discussed as part of the annual performance review.Conducting at least quarterly group meetings with the entire Sterility Assurance, micro, and quarantine service units to discuss future challenges.Ensuring all documentation is prepared, reviewed, and revised as required, including sterilization protocols, ECA excursions, micro investigations, TI, and specifications.Establishing environmental objectives and targets for continuous improvement across all assigned sites.Combining regulatory guidelines with actual test results and practices to create knowledge for advancing quality improvement initiatives.Supervising the Sterility Assurance Advisor and the Microbiology Laboratory and Product Disposition personnel for all assigned sites.Coaching and developing direct report subordinates.Ensuring inter-departmental compliance with company policies and corrective actions for all assigned sites.Qualification Knowledge SkillsBachelor’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.Travel: 20-25%#IJ #J-18808-Ljbffr