Quality Manager (Third Party Quality) – 12/24 Month Contract – Anywhere in Europe

Quality Manager (Third Party Quality) – 12/24 Month Contract – Anywhere in Europe page is loaded Quality Manager (Third Party Quality) – 12/24 Month Contract – Anywhere in Europe Apply locations Ireland Remote Office Poland Remote Office Milan, Lombardy, Italy United Kingdom Remote Office time type Full time posted on Posted 20 Days Ago job requisition id R5639031 3825 Upjohn Manufacturing Ireland Unlimited 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. Every day, we rise to the challenge to make a difference and here’s how the Quality Manager (Third Party Quality) role will make an impact: Key responsibilities for this role include: Viatris Third Party Quality is responsible for the Quality management of over 100 contract manufacturers, packagers, and supply partners globally, covering approximately 7,000 SKUs in 165 markets.The person will be responsible for contract quality assurance & regulatory change management for a number of key contractors & projects planned over the next one to two years. I nitiate, review and approve regulatory changes in the regulatory systems for changes initiated by or impacting TPQ managed Contract manufacturers. Act as liaison between regulatory and CMO for generation of filing information for projects and review the associated regulatory submission documents. Participate in Virtual Site Operating Teams (VSOT), Virtual Project Team (or similar) meetings for ES/TPQ managed Contract manufacturers & participate in Site Quality visits at the Contract manufacturers, if needed. Provide Quality Leadership for significant deviations at CMO sites that may impact compliance status or require regulatory notifications. Prepare Critical Quality Event (CQN) summaries and participate in relevant meetings. Provide Quality leadership for customer complaint investigations. Support and Perform Lot Disposition, if required, in collaboration with other functions. Lead and/or provide support to other quality projects and continuous improvement initiatives within TPQ and External Supply, as required. Perform and assist with additional duties as may be directed by Director/TL, Viatris Third Party Quality. The role is remote and can be located in Europe. The minimum qualifications for this role are: 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. Good command of English language and multi-lingual is a benefit. Strong verbal and written communication skills including presentation skills. Able to work in diverse multi-level, cross-divisional and multi-cultural working environment. Able to work remotely and deliver work independently. Take initiative and be proactive. Show strong negotiation skills and customer focus. Is diplomatic in communication with internal and external customers. Demonstrate ability to prioritize work, manage multiple projects, act and work independently and to report items as required. A t Viatris, we offer competitive salar ies , 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. About Us Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce of 45,000, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance. We believe in healthcare as it should be – empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them. J-18808-Ljbffr