Senior QA Operations Officer

Senior QA Operations Officer

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 realize 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

Every day, we rise to the challenge to make a difference and here's how the Senior QA Operations Officer role will make an impact:

1. Manage and oversee the review of manufacturing and packaging documentation, including both electronic and paper batch records for pharmaceutical and medical device products.
2. Lead the QA Operations team, including setting performance objectives, conducting appraisals, managing training, and ensuring departmental flexibility in workload management.
3. Ensure right-first-time (RFT) batch file reviews for Qualified Person (QP) approval and on-time batch release to meet plan adherence and schedule attainment targets.
4. Manage deviation investigations, change control processes, and customer complaint investigations to ensure timely resolution and regulatory compliance.
5. Generate, monitor, and report on key quality metrics (daily, weekly, monthly, annually) to support business performance and compliance.
6. Drive adherence to safety policies, procedures, and environmental regulations while proactively identifying and mitigating risks.
7. Actively promote a culture of Quality and Continuous Improvement through training, engagement initiatives, Gemba walks, and GMP projects.
8. Coordinate QA Operations participation in regulatory, customer, and internal audits, ensuring inspection readiness at all times.
9. Support and participate in structured problem-solving initiatives, including risk assessments, RCA, HEP, and CAPA management.
10. Deliver budgeted cost improvement initiatives without compromising quality, while maintaining high standards in batch review and compliance processes.
11. Ensure all training requirements for self and team are completed on time, including preparation and delivery of GMP training modules as required.

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:

• Previous experience in Quality Assurance within the pharmaceutical or medical device industry.
• Strong understanding of cGMP, EU GMP Directives, and regulatory requirements.
• Proven experience in managing QA teams and leading performance and development initiatives.
• Demonstrated expertise in batch documentation review, deviations, change control, and CAPA management.
• Experience in supporting regulatory inspections and customer audits.
• Strong analytical, problem-solving, and decision-making skills with a pragmatic approach to quality operations.
• Excellent communication and interpersonal skills with the ability to engage, coach, and influence cross-functional teams.
• Track record of driving continuous improvement and cost efficiency within a QA function.

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you're excited about this role but your past experience doesn't fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

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. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.

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 https://www.viatris.com/en/Careers/Diversity-and-Inclusion

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 https://www.viatris.com/en/about-us/corporate-responsibility

Viatris is an Equal Opportunity Employer.