Sterility Assurance Lead

Mylan Teoranta

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via: 

Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and 
Partnership – Leveraging our collective expertise to connect people to products and services. 

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

The Sterility Assurance Lead 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 Sterility Assurance Lead will make an impact:

• Driving Sterility Assurance Strategy:

• Oversight of Environmental Monitoring and Contamination Control:

• Support for Sterility-Related Validations and Audits:

• Leadership and Collaboration:

• Documentation and Reporting:

• Instrument and System Management:

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Educational Background: A Bachelor’s degree in Microbiology, Biotechnology, or a related discipline, with 2–4 years of sterility assurance or aseptic manufacturing experience.

• Regulatory Knowledge: Strong understanding of Annex I, US, and EMA GMP regulations, with practical experience in regulatory audits.

• Aseptic Process Expertise:

• Leadership Skills: 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 role focuses on establishing a robust sterility assurance culture, ensuring patient safety through the highest levels of contamination control, process integrity, and regulatory compliance.

Benefits at Viatris

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:

• Excellent career progression opportunities

• Work-life balance initiatives

• Bonus scheme

• Health insurance

• Pension

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. 

Viatris is an Equal Opportunity Employer.