Manager, Contractor Quality Lead

3839 Viatris Pharma S.r.l.

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 Manager, Contractor Quality Lead role will make an impact:
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 mínimal 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 Upjohn 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 as quality representative new product launches, new Business Development project 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.
- Primary focus of the role will be to support Outlicense/Supply/Distribution deals (21 to date) identified which require liaison, information sharing, review and approval of documents and generation of deal specific documents, eg APQR's, complaint trend evaluations et.

The minimum qualifications for this role are:

- Minimally BA/BS Science, Engineering, or related technical discipline
- Minimally 5 years in a GxP setting
- At least 3 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, must be also fluent in Arabic; 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 mínimal supervision
- Has excellent organization skills
- Demonstrated experience managing complex quality and complia