QA Supplier Senior Manager

The Quality Supplier manager is responsible for a wide range of activities/tasks related to the Quality oversight of external suppliers in charge of the manufacturing activities for a product. Acting as a single point of contact with the external supplier, the Quality Supplier manager has a key role to ensure compliance of the external supplier with current GMP & GDP regulations, the Quality Technical Agreement and with Sobi procedures and policies to enhance the product supply of medicines to consumers and to support the fast growth of Sobi. This role is also responsible for managing the quality interface and cross-functional relationships with Sobi stakeholders.Please note this is a remote position with travelKey Responsibilities Act as Single point of contact for all quality related activities at the External SupplierEnsure that all aspects of handling, manufacturing, distribution of products are in compliance with Sobi Quality system, the effective Quality Technical Agreement, that they meet relevant cGMP regulatory requirement.Lead External supplier QualificationEstablish Quality Technical Agreement and ensure valid QTA clearly defines roles & responsibilities between Sobi and the External SupplierImplementation and maintain Quality Risk Assessment and KPIs on Quality External activities.Define & Monitor Remediation plans to ensure that issues are suitably addressed. Drive or support improvement opportunities for processes and product Quality performance.Request, review GMP, GDP documentation as defined in the QTA and Sobi procedures.Ensure External supplier provides product reviews or data (APQR/PQRs, stability reports) as specified in the QTA.Assess the performance of the product and the process as per Sobi requirement.Manage / approve quality issues (deviations, CAPA and complaints) as per QTA and Sobi requirement.Responsible for ensuring Change requests either from the External Supplier or from Sobi are managed according to the QTA and Sobi requirements.Responsible for ensuring Quality Audits of the CMO is performed according to Sobi requirement and the QTA.Define strategy of implementation and monitoring of key Quality transformation initiatives and align with all process stakeholders outside of Quality organization.Act as Quality representative in project related to External supplier eg Tech Transfer, Launch.Assess and ensure External Supplier readiness for Health Authorities inspectionsSupport inspections/audits of Sobi.Responsible to inform Sobi management and cross functional teams of all critical & major issues and escalate any issues as per Sobi escalation policy.Ensure a good collaboration is maintained within the product team