Head of Sterility Assurance and Microbiology-Waterford Full Time

Purpose

As the Head of Sterility Assurance and Microbiology you will be responsible for developing and implementing effective strategies and procedures for sterility assurance and microbiology across the organization. This position will involve building and maintaining essential internal and external relationships to ensure technical expertise and support is provided to other departments and functions on matters related to sterility assurance.

You will also drive the development of process technical expertise within the sterility assurance department, ensuring regular presence on the shopfloor while coaching and developing knowledge of the operations teams.

Responsibilities:

• Develop and implement comprehensive sterility assurance and microbiological programs in alignment with the organizational strategy, vision, and objectives.
• Ensure the 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, with Q&V team, the validation, qualification and monitoring of methods, equipment and the environment ensuring sterility assurance control.
• Follow metrics and monitor data for the sterility assurance and microbiological activities, to identify trends and issues and to implement action plan.
• Promote a culture of quality throughout the organization, identifying and driving continuous improvement initiatives and projects to enhance the 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.
• Interact with external bodies & Global Quality to bring knowledge and awareness of best industry practices.
• Prepare and participate in regulatory inspections and audits, providing expertise on sterility assurance and microbiology.

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.
• Strong communication, decision-making, and analytical skills.
• Proficient in Lean Principles and process control strategies to enhance operational effectiveness