Third Party Quality Assurance Associate

ROLE SUMMARY

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 is a new kind of healthcare company, committed to providing access to medicines, advancing sustainable operations, developing innovative solutions and leveraging our collective expertise to improve patient outcomes. Formed in 2020 through the combination of Mylan and Pfizer Upjohn, Viatris brings together best-in-class scientific, manufacturing and distribution expertise with proven regulatory, medical and commercial capabilities to deliver quality medicines to patients when and where they need them.

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.

Viatris Third Party Quality is responsible for the Quality management of over 90 contract manufacturers, packagers, and supply partners globally, covering approximately 7,000 SKUs in 165 markets.

The person will be responsible for regulatory change management activities as a Site Compliance Network Member (SCNM) for a number of product transfers to CMO's planned over the next year.

ROLE RESPONSIBILITIES

The Third Party Quality Assurance Associate is accountable for the regulatory activities for a number of key projects relating to the Viatris External Supply Portfolio and quality systems supporting these. These critical projects include product launches from alternative CMO's sites, integration into a new business, support for changes in legal entity names across the market, License holder changes, product and packaging branding changes and update to work processes supporting these and others.

Reporting to the Snr Manager, Contract Quality Lead, Viatris Third Party Quality. Key responsibilities include but not limited to:

• Serve as the main point of contact for the Global Chemistry, Manufacturing and Controls (GCMC) department or Local Regulatory Affairs in the Viatris Country Offices (for Single market products) for the various regulatory activities involving TPQ managed Contract manufacturers.
• 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.
• 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 with Contract manufacturers & participate in Site Quality visits at the Contract manufacturers, if needed.
• Support SAP related tasks and Perform Lot Disposition, if required, in collaboration with other functions.
• Lead and/or provide support to other quality projects and continuous improvement initiatives, as required.
• Perform and assist with additional duties as may be directed by Snr Manager, Contract Quality Lead.

QUALIFICATIONS

Min. BA/BS in Science, Engineering, Pharmaceutical Sciences or related technical discipline

• Min. 3 to 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
• 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 to Team Leader
• Take initiative and be proactive
• Up to 10% travel maybe required to meetings in Cork / Dublin offices.