Supply Chain Quality Manager

‎3823 Upjohn Export B.V. (Saudi Arabia)
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
Supply Chain Quality Manager role will make an impact:
Key Responsibilities Include
The Supply Chain Quality 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 Supply Chain Quality Manager-Middle East Region.
* 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 (TrackWise).
* 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.
* Performs local release of API, Semi Finished Products and Finished Goods for the CMO, in compliance with the applicable local regulations and local procedures, prior to distribution/sale within country.
* 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 local Saudi Quality Operation identified which require liaison, information sharing, review and approval of documents and generation of deal specific documents, eg APQR's, complaint trend evaluations et.
* Provide Quality Leadership within the cross functional teams
* Participate in the establishment and maintenance of a Quality Management System and Quality Culture within Viatris Country in compliance with internal and Regulatory Authority expectations.
* Participate in GDP/GMP internal audits and regulatory inspections within Viatris Country Office
* Track quality metrics, assess risks and implement actions to continuously improve performance
* Resolution of Product Quality and Compliance Issues
* Contributes to ensuring a quality system setting out responsibilities, processes and risk management principles is implemented and maintained for the distribution activities carried out by Viatris Country.
* Contributes to ensuring that initial and continuous training programs are implemented and maintained for all relevant Viatris Country colleagues involved in distribution activities.
* Participates in the risk management process activities for the distribution activities carried out by Viatris Country.
* Performs self-inspections at appropriate regular intervals following a pre-arranged program and tracks the implementation of the necessary corrective measures.
* Monitors and assesses new quality system/local regulatory requirements and adjusts/enhances local systems and processes when required. Notifies local and functional management about relevant changes.
* Ensures that any additional national legal requirements imposed on certain products or activities are adhered to.
The Minimum Qualifications For This Role Are
* Eligible to fulfil the role of Quality Representative Person for Viatris Saudi as per SFDA legislation
* Qualified for holding the Narcotic Custodian for Viatris Saudi.
* Holds a degree in Pharmaceutical Sciences
* 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 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
Experience
* Minimally ‎5 years in a GxP setting
* At least ‎3 years of Product Quality Assurance experience in a GMP environment
At Viatris, we offer competitive salaries, benefits and an 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.