Vendor Quality Lead
Contracting Brabant Wallon
Your responsibilities:
1. Be the central QA point of contact for the organization for investigations/deviations/ out of specifications/ audit observations associated with the assigned vendors. Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders (Vendor Team, GQL, CAS, Business) to allow assessment.
2. Manage the key performance indicators (metrics) for key operational QA activities and services associated with the vendors in the defined described tracking tools (Vendor QA KPI tracker, QuickScore) and track the vendors performance
3. Ensure all Quality agreements are in place and take ownership of agreements for the vendors. Maintain Quality Agreement with the vendors up to date and perform periodic reviews and update of the agreement in close collaboration with the product GQLs and the vendors.
4. When applicable, be sure that the Annual Product Stability Program is rolled out and executed at the vendor in accordance with the Stability Program
5. Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed, are reviewed within the requested time period. Ensure that this review is documented and made available in the Controlled Documents System.
6. Participate as QA representative to the recurrent vendor meetings, present issues and resolutions, and drive vendor quality performance through these meetings
7. Quality Complaints: Be the contact person for the follow up with vendors for the manufacturing investigation part. When applicable, ensure that initial receipt, logging of quality complaints into the Complaint System and provision of responses to the complainant are professionally coordinated and managed.
8. If needed work with the Vendor team and Global Quality Lead to determine the Root cause of issues which may lead to a Corporate Technical Review (CTR) meeting. Coordinate vendor quality related investigations
9. Participate on ad hoc basis to the Product Change Control Committees for activities related to the vendors
10. Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors
11. Work closely with Corporate QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way
12. Cover the entire product life cycle from initial commercialization including Technology Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements to phase out for the assigned vendors
13. Developer and owner of the QA plans and product resource and capacity overview for activities associated with the assigned vendors
14. Ensure all relevant documentation are provided to the vendors and implemented (Methods, Spe