Senior Manager Sterility Assurance

Senior Manager Sterility Assurance

Viatris

Inverin, Ireland

The Role & What You Will Be Doing

Senior Manager Sterility Assurance plays a pivotal role in ensuring the sterility of injectable products through robust contamination control and sterility assurance strategies. This role extends beyond microbiological testing to encompass comprehensive oversight of aseptic manufacturing, contamination risk management, and adherence to global regulatory requirements. It involves close collaboration across departments to drive sterility assurance initiatives while fostering a culture of quality excellence

Key Responsibilities

Every day, we rise to the challenge to make a difference and here’s how the Senior Manager Sterility Assurance will make an impact:

• Lead the site Sterility Assurance strategy and program, ensuring compliance with EU GMP Annex 1 and global regulatory requirements;
• Develop and maintain the Contamination Control Strategy (CCS) to support sterile manufacturing operations;
• Conduct risk assessments for aseptic processes, environmental monitoring, and container closure systems to mitigate contamination risks;
• Oversee and continuously improve the environmental monitoring program to ensure robust contamination control;
• Lead and support microbiological investigations, ensuring appropriate root cause analysis and effective CAPA implementation;
• Coordinate and oversee aseptic process simulations (media fills) and support review and approval of related documentation;
• Support validation and qualification activities related to sterility testing, aseptic processes, and laboratory systems;
• Represent sterility assurance in internal and external audits and regulatory inspections, addressing observations and driving corrective actions;
• Collaborate cross-functionally with Quality, Manufacturing, Engineering, and Microbiology teams to ensure alignment on sterility assurance practices;
• Maintain and approve key sterility assurance documentation, including SOPs, validation protocols, and contamination control plans;
• Monitor and report sterility assurance performance metrics and trends, driving continuous improvement across the site.

About Your Skills & Experience

The successful candidate will have the following qualifications, skills, and experiences:

• A Bachelor’s degree (or higher) in Microbiology or a closely related field (e.g., Biotechnology);
• Extensive years of experience in sterility assurance, aseptic manufacturing, or a related field, with a strong emphasis on microbiology and contamination control is needed;
• Aseptic Process Expertise:
  • Proven experience in contamination control strategies, including cleaning and disinfection validation;
  • Hands-on experience with isolator technology, environmental monitoring, and aseptic processing validations…(List areas of Knowledge required
• Deep understanding of Annex I, US, and EMA GMP regulations and their application in sterility assurance;
• Hands-on experience in regulatory audits, with a solid track record of compliance and audit readiness in sterile environments;
• Strong ability to mentor and develop teams, lead investigations, and drive sterility assurance initiatives;
• Risk Assessment & Problem-Solving: Experience in sterility-related risk assessments, deviation investigations, and implementing corrective/preventive actions;
• Technical Proficiency: Proficient in the use of contamination control tools and monitoring systems, including MODA, Excel, and project management software;
• Communication & Collaboration: Excellent ability to articulate sterility assurance concepts and collaborate cross-functionally to drive compliance and process improvements.

This is a senior role that requires an in-depth understanding of microbiological principles as they apply to sterility assurance. You will play a critical role in ensuring the highest standards of aseptic manufacturing, contamination control, and compliance across our production processes. If you have a pure microbiology background and bring extensive hands-on experience in sterility assurance, we’d love to hear from you.