Major Accountabilities

? Responsible for ensuring quality oversight for purchased APIs and strategically important regulatory starting materials and chemical intermediates supplied into Novartis NTO sites worldwide.

? Participate in and approve changes of supplier qualification and certification status for all external Suppliers, and maintain all associated quality systems e.g. maintain and update documents related to the supplier qualification and monitoring.

? Participate in escalation of all potential quality issues as per the Novartis escalation policy to higher level management, especially to the QA Lead and ESO Global QA Head Chemicals & Anti-infectives, and initiating all actions as required. (483’s, Warning Letters, FDA Field Alert Reports, Notifications to the Drug Shortage Office etc).

? Manage major and critical quality issues (Complaints, deviations, recalls, counterfeits, product tampering, stability failures and any regulatory non-compliance identified, as applicable) according to the Quality Agreement and the Novartis Quality Manual. Ensure investigations are correctly executed and all appropriate Corrective and Preventative actions are put in place in a timely manner.

? Perform risk assessments in case of specific quality events at supplier, including collecting relevant data from NTO sites and other stakeholders, and approval of site specific risk assessments where required. Evaluate risks for product quality and patient safety and proposes market actions

? Participate in High Risk Supplier evaluation process, and ensure that actions originating from this process are executed and properly documented. Proactively communicate supplier status changes (incl. high risk suppliers) with NTO sites.

? Provide direction and support to third parties and ensure that they are qualified, achieve a high level of competence and are motivated to carry out their duties to ensure that the materials produced meet the Novartis quality, efficacy and safety requirements.

? Travel to external supplier manufacturing sites during audits, for continuous improvement activities or to resolve any issues.

? Responsible for preparing Quality Agreements and Quality Risk assessments for all External Suppliers within the responsibility of the team, and for maintaining documentation in relevant IT systems.

? Support remediation of any gaps identified in Quality Systems and ensure any issues are addressed.

? Provide the quality presence and in-put to Technical Meetings with the external suppliers and establish good working relationships with clear communication and defined actions and goals.

? Request, review and process GMP documentation as defined by the Quality Agreement and Novartis SOPs. Manage the Quality Aspects of the relationship in accordance with the effective 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 carried out according to the Novartis Quality Manual - maintain an annual auditing program, participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs (QARP, FURP). Maintain and update documents related to the audits in the relevant systems.

? Ensure that Change requests, either from the External Supplier or from Novartis, are raised in the Novartis Change Control system, and where applicable, are managed according to the Quality Agreement and Novartis SOPs from receipt, through to the implementation and closure.

? Ensure that coordinated contact is maintained with other Functions within Novartis also dealing with External suppliers namely Purchasing, Legal, Supply Chain, Regulatory CMC, Drug Regulatory Affairs, Group Quality Operations (GQO), etc.

? Support site readiness for regulatory inspections at External suppliers where appropriate, and support site remediation from inspections where required.

? Ensure that support is provided to NTO sites in their preparation for Novartis or Health Authority general GMP inspections and PAI inspections.

? Performing technical visits of suppliers, issue technical visit reports and perform follow-up.

? Act as a person in plant (PIP) when necessary in some specific suppliers to ensure on site supervision of critical activities and to provide formal reports to Novartis regarding activities performed.

? Support Regulatory CMC in compilation of responses to HA queries, and review source documents for Regulatory submissions as required

Inside the Organisation

? Implement and maintain local Quality Systems and Standard Operating Procedures defining all the processes for managing of External suppliers.

? Ensure that the ESO QA Lead, Global QA Head and the Supplier Relationship Manager is 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.

? Participate in the Business review of External suppliers.

? Participate in the Reporting on QA External Supplier activities - this is to include Risk Assessment, reporting and managing of defined KPI's.

? Ensure that coordinated contact is maintained with other functions within Novartis also dealing with External suppliers namely Purchasing, Legal, Supply Chain, Regulatory CMC, Drug Regulatory Affairs, Group Quality Operations (GQO), etc.

? Support execution of the ESO Quality Plan.

? Participate in projects as defined and ensure that all aspects are implemented and followed up

? Support the team in achieving targets defined in ESO Q-plan

Personal development

? Maintain current knowledge of local and international regulatory and legislative requirements

and trends

Ideal Background

Education:Bachelor or higher in Biochemistry, Chemistry or another related science

Languages: Fluent in speaking I writing in English

Experience:

10 or more years experience in the pharmaceutical industry, with direct experience with APIs. Experience in QA Operations, production, QC and/or other relevant operational areas, but must include

minimally 5 years in QA, and 3 years of management and or project management experience. Thorough knowledge of cGMP requirements.

? Strong understanding of regulatory requirements for commercial products

? Proven track record with FDA, EMEA and other Health Authorities.

? Strong understanding of risk assessment and risk management fundamentals/tools

? Technical understanding of pharmaceutical I biological processes

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