Ext. Supply Quality Assurance Manager

Responsible for managing quality aspects at external suppliers for Biopharmaceuticals /Pharmaceuticals/Devices and to ensure that the operational business is in compli-ance with cGMP, the Quality Assurance Agreement, regulatory requirements and the Novartis Pharma Quali-ty Manual and is conducted according to the relevant SOP's.
- Lead External Suppliers Qualification process
- Act as Single Point of Contact/SPOC for all quality related activities at the External Supplier
- Ensure that all aspects of the handling. manufacturing and distribution of biophar-maceuticai/pharmaceutical products are in compliance with the Novartis Pharma Quality Man-ual, the effective Quality Agreement. that they meet relevant cGMP regulatory requirements and are conducted according to local SOP's
- Responsible for driving/initiating External Supplier Quality Risk assessments to be carried out for all External Suppliers. Gaps in Quality Systems to be identified with an evaluation of the associated risks. Remediation plans are to be defined and execution is to be monitored to ensure that issues are suitably addressed
- Provide the quality presence and in-put to Technical Meetings with the External Suppliers and establish good working relationships with clear communication and de-fined actions and goals
- Ensure that a valid QA Agreement defined on line with the requirements Global template is in place which clearly defines cGMP roles and responsibilities between Novartis and the Exter-nal Supplier, as well as Product details and requirements
- Request, review and process GMP documentation as defined by the Quality Agreement and Novartis SOP's. Manage the quality aspects of the relationship in accordance with the effec-tive Quality Agreement. Perform the required periodic review and make recommendations for amendments to the agreement based on identified needs and issues
- Responsible for coordinating and ensuring that Quality auditing of External suppliers is car-ried out according to the Novartis Quality Manual - maintain an annual auditing program. par-ticipate in and/or lead audits. manage action plans and follow up on agreed upon CAPA's. Ensure site readiness for regulatory inspections at External sup-pliers where appropriate
- Manage all critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc.) according to the Quality Agreement and the Novartis Quality Manual. Ensure investigations are correctly executed
- Support/participate in Novartis Emergency Management cases as required
- Ensure that Change requests, either from the External Supplier or from Novartis, are managed according to the Quality Agreement and Novartis SOP's from receipt, through to the imple-mentation and closure
- Responsible for assessing quality trends and driving continuous improvement for process and product quality performance
- Ensure that the External Supplier provides the required product review or the data as speci-fied in the relevant Quality Agreement on an annual basis. Critically assess the performance of the product and process and provide the assessment to the report annually
- Escalade any issues or instances of instability per the Novartis escalation policy, and initiate any market action that is required within the organization.
- Support the implementation and maintain a local Quality System and Standard Operating Procedures defining all the processes for managing of External suppliers
- Ensure that the External Supply Global QA Head and the Supplier Relationship Man-ager are kept informed of all critical and major issues which may have an adverse effect on the quality of the product at an External Supplier
- Together with the Supplier Relationship Manager provide direction, formulate strategies and make decisions which ensure the efficient operation of the External Supplier business as a whole - Participation in the Business review of External Suppliers
- Participate in the Reporting on QA External Supplier activities - this is to include Risk As-sessment, reporting and managing of defined KPl's
- Ensure that coordinated contact is maintained with other functions within Novartis also deal-ing with External Suppliers namely Purchasing, Legal, Supply Chain, Regula-tory CMC, Drug Regulatory Affairs, Group Quality Operations (GQO), etc
- Participate in the ESO Quality Plan - ensure that all quality issues at External Suppliers are included in this plan Participate in projects as defined and ensure that all aspects are imple-mented and followed up
- Personal Development
- Maintain current knowledge of local and international regulatory and legislative requirements and trends

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**
- Education (minimum/desirable): Pharmacy graduate ,
- Languages: French : Fluent (mandato