Senior Manager Sterility / Microbiology

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 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 meeting 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, TI 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.
• Supervises directly the Sterility Assurance Advisor and the Microbiology Laboratory and Product Disposition personnel for all assigned sites.
• Coaches and develops direct report subordinates.
• Is responsible for inter-departmental compliance with company policies and corrective actions for all assigned sites

Qualification Knowledge Skills

• Bachelor’s degree in science, Microbiology or biological science preferred.
• Masters 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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