Job Title
Sr. Manager, Sterility & Microbiology
Position Summary:
The Senior Manager, Sterilization & Microbiology will lead and develop a team of microbiologists while ensuring completion of all microbiological and bio-analytical testing.
Key Responsibilities:
1. Ensure product disposition plan attainment and compliance with quality requirements for all assigned sites.
2. Manage the Sterilization Controls Subsystem related activities for all assigned sites.
3. Partner with Site/Divisional Business Quality Leads to ensure local quality metrics are met.
4. Manage the Sterility Assurance teams for all assigned sites 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 proactive functions to impact production, improve efficiency in micro lab, solve problems during sterilization validation, and provide new product support in ECA and micro testing.
8. Evaluate performance via performance appraisal and ensure employee development plans are discussed as part of annual reviews.
9. Prepare, review, and revise documentation as required, including sterilization protocols, ECA excursions, micro investigations, and specifications.
10. Establish environmental objectives and targets for continuous improvement at all assigned sites.
11. Combine regulatory guidelines with actual test results and practices to advance quality improvement initiatives.
12. Supervise the Sterility Assurance Advisor, Microbiology Laboratory, and Product Disposition personnel for all assigned sites.
13. Coach and develop direct report subordinates.
14. Ensure inter-departmental compliance with company policies and corrective actions for all assigned sites.
Qualifications:
1. Bachelor's degree in science, Microbiology, or biological science preferred.
2. Masters degree desirable.
3. 10+ years of experience in microbiology lab in medical device or pharmaceutical industry.
4. ISO Lead Auditor training, desirable.
5. Certified Quality Engineer (ASQ), desirable.
Travel: 20-25%