Senior Manager Sterility Assurance

Mylan Teoranta Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. We have been included on number of award lists that demonstrate the impact we are making.   Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment. For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world. 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