Job Summary
The Head of Sterility Assurance and Microbiology will oversee the development and implementation of sterility assurance and microbiological procedures and strategies across a global BioPharmaceutical organization.
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Responsibilities
* Develop and implement comprehensive sterility assurance and microbiological programs in alignment with organizational strategy, vision, and objectives.
* Ensure compliance of products and processes with applicable sterility assurance and microbiology regulatory requirements and company quality standards.
* Maintain a system to ensure sterility assurance and microbiological risks are properly identified, tracked, and mitigated.
* Oversee validation, qualification, and monitoring of methods, equipment, and environment ensuring sterility assurance control.
* Follow metrics and monitor data for sterility assurance and microbiological activities to identify trends and issues and implement action plans.
* Promote a culture of quality throughout the organization identifying and driving continuous improvement initiatives and projects to enhance sterility assurance and microbiological activities.
* Evaluate and recommend new technologies, tools, and methods to enhance sterility assurance and microbiology.
* Lead management reviews to assess the effectiveness of the sterility assurance program and microbiological program.
* Lead and manage the sterility assurance and microbiology team including hiring, training, coaching, professional development, and performance evaluation.
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Requirements
* Degree and/or Master's in a science or engineering discipline.
* Over 10 years of experience in the Pharma industry with at least 5 years in a leadership role within aseptic/sterile manufacturing or Microbiology.
* Proven experience in microbiology and sterile manufacturing.
* Strong leadership and experience in developing and mentoring technical teams.
* Expertise in aseptic manufacturing, regulatory requirements, and product technical transfer.