Requirements: English
Company: TN Switzerland
Region: Selzach , Soleure
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Senior Manager Sterility / Microbiology, Selzach
Client:
Stryker Ireland, Ltd.
Location:
Job Category:
Other
-
Job Reference:
3182dbe09f19
Job Views:
5
Posted:
28.04.2025
Expiry Date:
12.06.2025
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
- Ensuring 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.
- Manage the Sterility Assurance teams for all assigned sites to continuously fully comply with all quality and regulatory standard requirements.
- Assist during 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 that are done in the microbiology laboratory.
- 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.
- Evaluate performance via performance appraisal and ensure employees development plan is discussed as part of annual performance review. Conduct at least quarterly group meetings with entire Sterility Assurance, micro, and quarantine service units and discuss future challenges.
- Ensure that all documentation is prepared, reviewed, and revised, as required including sterilization protocols, ECA excursions, micro investigation, TIs, and specifications.
- Establish environmental objectives and targets for his/her area that will provide continuous environmental improvements for all assigned sites.
- Combine regulatory guidelines with actual test results and practices to create knowledge for advancing quality improvement initiatives.
- Supervise directly the Sterility Assurance Advisor and the Microbiology Laboratory and Product Disposition personnel for all assigned sites.
- Coach and develop direct report subordinates.
- Responsible for inter-departmental compliance with company policies and corrective actions for all assigned sites.
Qualification, Knowledge, Skills
- Bachelors degree in science, Microbiology or biological science preferred.
- Master''s degree desirable.
- 10+ years of experience in microbiology lab in medical device or pharmaceutical.
- ISO Lead Auditor training, desirable.
- Certified Quality Engineer (ASQ), desirable.
Travel: 20-25%
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Travel Percentage: 30%
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