Senior Manager Sterility / Microbiology Position Overview
The Senior Manager, Sterilization & Microbiology will lead and develop a team of microbiologists ensuring completion of all microbiological and bio-analytical testing.
Main Responsibilities:
1. Ensure product disposition plan attainment and that all products released meet quality requirements for assigned sites.
2. Manage Sterilization Controls Subsystem activities for assigned sites.
3. Partner with Site/Divisional Business Quality Leads to ensure local related quality metrics are met.
4. Manage Sterility Assurance teams to comply with quality and regulatory standard requirements.
5. Assist in implementing quality and regulatory requirements (FDA, EU, GLP, and guidelines) and ensure compliance with testing SOP and specifications.
6. Monitor testing techniques and accuracy of records and documentation in the microbiology laboratory.
7. Initiate pro-active functions to impact production, increase efficiency in micro lab, solve problems generated during sterilization validation, improve and provide new product support in ECA and micro testing.
8. Evaluate performance via performance appraisal and ensure employees development plan is discussed as part of annual performance review.
9. Conduct quarterly group meetings with Sterility Assurance, micro, and quarantine service units and discuss future challenges.
10. Prepare, review, and revise documentation including sterilization protocols, ECA excursions, micro investigation, TI and specifications.
11. Establish environmental objectives and targets for his/her area to provide continuous environmental improvements.
12. Combine regulatory guidelines with test results and practices to create knowledge for advancing quality improvement initiatives.
13. Supervise Sterility Assurance Advisor and Microbiology Laboratory and Product Disposition personnel.
14. Coach and develop direct report subordinates.
15. Be responsible for inter-departmental compliance with company policies and corrective actions.
Requirements:
1. Bachelor's degree in science, Microbiology or biological science preferred.
2. Master's degree desirable.
3. 10+ years of experience in microbiology lab in medical device or pharmaceutical.
4. ISO Lead Auditor training, desirable.
5. Certified Quality Engineer (ASQ), desirable.
Travel: 20-25%