Position Summary :

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.

Position Responsibilities :

The Contractor Quality Lead Manager is accountable for providing quality assurance management of key contractors in the Global Integrated Oral Solid Dose (OSD) and API External Supply portfolio and for assuring that the products supplied to our patients are manufactured, tested in accordance with cGMPs, the registration file and any additional country specific requirements.

This is highly independent position operating with minimal supervision, interacting with high levels of management both at contract manufacturers and within Viatris. (S)he will operate as spokesperson for Third Party Quality and will spend a significant period of time developing relationships, independently negotiating, developing and communicating Viatris quality requirements with contract manufacturers.

The Contract Quality Lead Manager will have significant interactions with many internal business and manufacturing organizations (e.g. External Supply, Regulatory, Technical Support, Global Quality, Internal sites and R&D) and will lead and participate in virtually based cross functional teams. (S)he will report to the Director/Team Leader, Third Party Quality. Key responsibilities include:

• Provide Quality Leadership within the cross functional virtual site operating teams (VSOT).

• Lead the development, implementation and support of QA/QC systems for products processed and produced by CMOs

• Support new product launches and technology transfers.

• Partner with colleagues to develop and negotiate quality agreements.

• Drive the development, implementation and continuous improvement of Quality Systems to support regulatory requirements.

• Proactively support regulatory inspections at CMO's and ensure appropriate Viatris review/approval of responses to Regulatory Agencies including tracking of CAPA's within Quality Tracking System (QTS).

• Provide Quality Leadership for change management and significant deviations at CMO sites that may impact compliance status or require regulatory notifications.

• Provide Quality Leadership and author support documentation for individual market release supporting documents to meet local regulatory requirements.

• Ensure implementation of effective CAPA and quality system improvements based upon determined remediation activities.

• Prepare Critical Quality Event (CQN) summaries and participate in relevant meetings.

• Lead quality risk management activities and manage mitigation plans within CMO's.

• Accountable for the on-time disposition of commercial products in line with agreed schedule.

• Provide Quality leadership for customer complaint investigations.

• Provide support for regulatory activities involving TPQ managed Contract manufacturers.

• Lead and/or provide support to quality projects and continuous improvement initiatives within TPQ and External Supply.

Qualifications:

• Minimally BA/BS Science, Engineering, or related technical discipline

• Minimally 10 years in a GxP setting

• At least 5 years of Product Quality Assurance experience in a GMP environment

• Experience with external suppliers/contractors is preferred

• Advanced computer skills, MS Office and enterprise systems such as SAP, Trackwise, Documentum platforms

• Command of English language required, and multi-lingual is beneficial.

• Strong verbal and written communication including presentation skills

• Shows strong negotiation skills

• Is diplomatic in communication with internal and external customers

• Demonstrated ability to manage multiple projects and complex contractors

• Demonstrated 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 environment

• Operates with minimal supervision

• Has excellent organization skills

• Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor

• Demonstrated personal leadership to manage cross functional projects

• Demonstrated ability to resolve conflicts

• Takes initiatives and is proactive, persistent

• Has a strong broad GMP and technical know-how to handle emerging issues

Travel Requirements :

• Up to 30 % travel required

Organizational Relationships:

The incumbent will have strong business line connections to multiple internal and external stakeholder groups. Specifically, internal relationships with both Viatris and Integrated OSD and API organizations such as External Supply and Third Party Quality, New Business Development, Global Technical Services, Global Quality Operations, Internal Site Leadership teams, Regulatory, Medical, Safety and Legal teams.

The Contract Quality Lead will also operate as spokesperson for and will spend a significant period of time developing external relationships, independently negotiating issues, developing and communicating quality requirements with contract manufacturers, distributors and partners.