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 Lead (Projects), Third Party Qualityrole will make an impact:
Provide Quality Leadership and guidance within the cross functional virtual project teams.Provide Quality oversight and decision making relating to technical changes and validation activities at Contract Manufacturing Organizations (CMO's), e.g.
tooling/equipment changes (trade dress)Stability protocol generation and approval.Change control management and approvalValidation protocol review and approvalSupport the TPQ QSOS colleagues who will act as liaison between regulatory and CMO for generation of filing information for these projects, and who will review the associated regulatory submission documents.Coordinate and communicate with all other impacted upstream/downstream sites, market quality and regulatory colleagues as well as project team leads for status updates and supply chain colleagues in order that contingency planning and stock build can be appropriately scheduled.
Quality approval of new SKUscreated for SAP change project, where the External Supply portfolio will transfer onto Viatris SAP systemLead 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 the Director/Team Leader Viatris Third Party Quality.The minimum qualifications for this role are:
Minimally BA/BS Science, or related technical disciplineMinimally 10 years in a GxP settingLeadership experience is desirable with a proven record of achievementsExperience with regulatory, and/or market quality, external suppliers/contractors quality is preferredAdvanced computer skills, MS Office and enterprise systems such as SAP, Trackwise, Documentum platformsCommand of English language required, and multi-lingual is beneficial.Strong verbal and written communication including presentation skillsShows strong negotiation skillsIs diplomatic in communication with internal and external customersDemonstrated ability to manage multiple cross functional projectsDemonstrated ability to prioritize work, to act and work independently and to report items as required to Team leader.Able to work in diverse multi-level, cross-divisional and multi-cultural working environmentOperates with mínimal supervisionHas excellent organization skillsDemonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractorDemonstrated ability to resolve conflictsTakes initiatives and is proactive, persistentHas a strong broad GMP and technical know-how to handle emerging issuesAt Viatris, we offercompetitivesalaries, benefitsandan 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.