Senior jobs in Deutschland

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Client:

Stryker Ireland, Ltd.

Location:

Kiel, Germany

Job Category:

Other

-

EU work permit required:

Yes

297b8f1a6646

2

16.05.2025

30.06.2025

Work Flexibility: Hybrid

Senior Manager, Sterility & Microbiology

Senior Director of Quality Assurance

The Senior Manager, Sterility & Microbiology will lead and develop a team of 4-7 microbiologists, ensuring the 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.

• Ensure product disposition plan attainment, and that all products released meet the pre-determined quality requirements for all assigned sites.
• Manage the Sterilization Controls Subsystem related activities for all assigned sites.
• Partner 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 ensure full compliance with quality and regulatory standards.
• Assist during implementation of quality and regulatory requirements (FDA, EU, GLP, and guidelines) and ensure compliance with testing SOPs and specifications.
• Monitor testing techniques and the accuracy of all records and documentation in the microbiology laboratory.
• Proactively initiate functions to impact production, increase efficiency in the micro lab, solve sterilization validation problems, and support new products in ECA and micro testing.
• Evaluate performance via performance appraisals and discuss employee development plans during annual reviews. Conduct quarterly meetings with Sterility Assurance, Microbiology, and Quarantine teams to discuss challenges.
• Ensure all documentation, including sterilization protocols, ECA excursions, micro investigations, TIs, and specifications, is properly prepared, reviewed, and revised.
• Establish environmental objectives and targets for continuous improvements across assigned sites.
• Integrate regulatory guidelines with test results and practices to foster quality improvement initiatives.
• Supervise directly the Sterility Assurance Advisor, Microbiology Laboratory, and Product Disposition personnel.
• Coach and develop direct reports.
• Ensure inter-departmental compliance with company policies and corrective actions across all sites.

• Bachelor’s degree in Microbiology, Biological Sciences, or related field; Master’s degree preferred.
• 10+ years of microbiology laboratory experience in medical device or pharmaceutical industries.
• ISO Lead Auditor training is desirable.
• Certified Quality Engineer (ASQ) is desirable.

Travel: 20-25%

#IJ

Travel Percentage: 30%