3825 Upjohn Manufacturing Ireland UnlimitedAt 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; andPartnership - 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 Manager - Quality Systems and Operational Support, Third Party Qualityrole will make an impact:
Initiate, review and approve regulatory changes in the regulatory systems for changes initiated by or impacting TPQ managed Contract manufacturers.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.Act as liaison between regulatory and CMO for generation of filing information and reviewing the associated regulatory submission documents.Provide support for the closure of Regulatory 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.Be the SME for working standards for regulatory change management, regulatory compliance requirements, qualityprocesses and is responsible for onboarding and training new QSOS colleagues.Departmental point of contact for regulatory systems (DPOC)Manage routine Customer Quality complaints for commercial Drug Products and work in collaboration with the TPQ Contractor Quality Lead to ensure that the investigation reports are appropriate and acceptable.
Ensure timely closure of complaints and alerting the appropriate colleagues as per procedure and Standard Work guidance.Support and Perform Lot Disposition, Product code approval in SAP, 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 minimum qualifications for this role are: