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
Viatris Third Party Quality (TPQ) is committed to supporting Viatris Global Integrated OSD and API External Supply Organisation as an innovative and competitive advantage for Viatris by assuring the quality of legacy Upjohn products manufactured and packaged by other companies (Contractors) for Viatris.
The Senior Associate Quality Systems & Operational Support (QS&OS) reports to the Director/Team Leader TPQ and will be responsible for regulatory change management activities as a Site Compliance Network Member (SCNM) for a number of product transfers to CMO’s.
Every day, we rise to the challenge to make a difference and here’s how the Senior Associate Quality Systems & Operational Support (QS&OS) role will make an impact:
Serve as the main point of contact for the Global Chemistry, Manufacturing and Controls (GCMC) department or Local Regulatory Affairs in the Country Offices for the various regulatory activities associated with the projects.
Provide support for the closure of CMC Commitments, Regulatory requests for regulatory submissions, Product registrations and Post approval variations.
Act as liaison between regulatory and CMO for generation of filing information for these projects and review the associated regulatory submission documents.
Become Quality systems SME to support the SAP change project, where the External Supply portfolio will transfer onto Viatris SAP system
Initiate, review and approve regulatory changes in the regulatory systems for changes initiated by or impacting TPQ managed Contract manufacturers.
Provide support for the closure of the deficiency letters and CMC Commitments, Regulatory requests for Renewals, New Product registrations and Post approval variations.
As the Regulatory Compliance and Product Complaint Expert, provide regulatory guidance for technical changes and critical quality events at Contract Manufacturing Organizations (CMO’s).
Participate in Virtual Site Operating Teams (VSOT) (or similar) meetings for ES/TPQ managed Contract manufacturers & participate in Site Quality visits at the Contract manufacturers, if needed.
Manage routine Customer Quality complaints for commercial Drug Products and work in collaboration with the TPQ Contractor Quality Lead for ensuring that the investigation reports are appropriate and acceptable. Ensure timely closure of complaints
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:
Min. BA/BS in Science, Engineering, Pharmaceutical Sciences or related technical discipline
Min. 5 years of experience in GXP setting and/or Regulatory Affairs role (or 3 years with Masters degree)
Advanced in computer skills such as MS Office applications and good knowledge of enterprise systems such as SAP, Regulatory systems, Trackwise, Documentum platforms
Travel up to 10% may be required
Good command of English language and multi-lingual is a benefit
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.
Why 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. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.
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 https://www.viatris.com/en/Careers/Diversity-and-Inclusion
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 https://www.viatris.com/en/about-us/corporate-responsibility
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.