Senior Manager Sterility Assurance, Galway

Senior Manager– Sterility Assurance 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

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.

Qualifications&Skills

A Bachelor’s degree (or higher) in Microbiology or a closely related field (e.g., Biotechnology).

Extensive experience in sterility assurance, aseptic manufacturing, or a related field, with a strong emphasis on microbiology and contamination control.

Proven experience in contamination control strategies, including cleaning and disinfection validation.

Hands‑on experience with isolator technology, environmental monitoring, and aseptic processing validations.

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.

Experience in sterility‑related risk assessments, deviation investigations, and implementing corrective/preventive actions.

Proficient in the use of contamination control tools and monitoring systems, including MODA, Excel, and project management software.

Excellent written and verbal communication skills, with the ability to articulate sterility assurance concepts and collaborate cross‑functionally.

This senior role 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.

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace. If you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply.

Benefits

Competitive salary and bonus scheme

Health insurance and pension

Career progression opportunities

Work‑life balance initiatives

Viatris is an Equal Opportunity Employer.

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