Senior Manager Sterility / Microbiology, Macroom
Client:
Stryker Ireland, Ltd.
Location:
Macroom, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
1ee016b60489
Job Views:
4
Posted:
19.04.2025
Expiry Date:
03.06.2025
Job Description:
Work Flexibility: Hybrid
Job Title: Senior Manager, Sterility & Microbiology
Reports To: Senior Director of Quality Assurance
Position Summary: The 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 Responsibility
1. Ensuring product disposition plan attainment, and that all products released meet the pre-determined quality requirements for all assigned sites.
2. Managing the Sterilization Controls Subsystem related activities for all assigned sites.
3. Partnering with Site/Divisional Business Quality Leads to ensure all local related quality metrics are met.
4. Manage the Sterility Assurance teams for all assigned sites to continuously comply with all quality and regulatory standard requirements.
5. Assist during implementation of quality and regulatory requirements (FDA, EU, GLP, and guidelines) and ensure compliance with testing SOP and specifications.
6. Monitor the testing techniques and accuracy of all records and documentation done in the microbiology laboratory.
7. Initiate pro-active functions to impact production, increase efficiency in the micro lab, solve problems generated during sterilization validation, and improve 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 the annual performance review. Conduct at least quarterly group meetings with the entire Sterility Assurance, micro, and quarantine service units and discuss future challenges.
9. Ensure that all documentation is prepared, reviewed, and revised, as required including sterilization protocols, ECA excursions, micro investigations, TI, and specifications.
10. Establish environmental objectives and targets for his/her area that will provide continuous environmental improvements for all assigned sites.
11. Combine regulatory guidelines with actual test results and practices to create knowledge for advancing quality improvement initiatives.
12. Supervises directly the Sterility Assurance Advisor and the Microbiology Laboratory and Product Disposition personnel for all assigned sites.
13. Coaches and develops direct report subordinates.
14. Is responsible for inter-departmental compliance with company policies and corrective actions for all assigned sites.
Qualification Knowledge Skills
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%
Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit.
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