Senior Manager Sterility / Microbiology

TN Germany; Kiel; Hybrid; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading company in the medical device industry seeks a Senior Manager for Sterility & Microbiology in Kiel. This role involves leading a team of microbiologists, ensuring compliance with quality standards, and managing sterilization controls. The ideal candidate will have extensive experience in microbiology and a strong background in quality assurance. This position offers hybrid work flexibility and opportunities for professional growth.

Qualifikationen

• 10+ years of microbiology laboratory experience in medical device or pharmaceutical industries.
• ISO Lead Auditor training is desirable.
• Certified Quality Engineer (ASQ) is desirable.

Aufgaben

• Lead and develop a team of 4-7 microbiologists.
• Ensure compliance with quality and regulatory standards.
• Monitor testing techniques and documentation accuracy.

Kenntnisse

Leadership

Quality Assurance

Microbiology

Regulatory Compliance

Ausbildung

Bachelor’s degree in Microbiology

Master’s degree

Jobbeschreibung

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Senior Manager Sterility / Microbiology, Kiel

Client:

Stryker Ireland, Ltd.

Location:

Kiel, Germany

Job Category:

Other

-

EU work permit required:

Yes

Job Reference:

297b8f1a6646

Job Views:

2

Posted:

16.05.2025

Expiry Date:

30.06.2025

Job Description:

Work Flexibility: Hybrid

Job Title

Senior Manager, Sterility & Microbiology

Reports To

Senior Director of Quality Assurance

Position Summary

The Senior Manager, 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.

Key Responsibilities

• 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.

Qualifications, Knowledge, Skills

• 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%