About the Role

　　Approve and maintain quality oversight with respect to supply of materials to Novartis, from global external suppliers of chemicals (strategic raw materials, Intermediates and Drug Substances) by working in Supply Relationship Teams. These materials are being supplied to >75 Novartis Technical Operation sites.

　　To ensure appropriate quality oversight, assessment and mitigation of quality risks, that may potentially negatively impact the supply of purchased strategic ESO chemicals (regulatory starting materials, Intermediates and APIs), and to ensure that all aspects of the relationship and management thereof, are in compliance with cGMPs, regulatory requirements, the Novartis Quality Manual and Pharma industry practices.

　　Your key responsibilities:

　　Your responsibilities include, but are not limited to:

　　• 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 Global QA Head ESO SM API, 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

　　Diversity & Inclusion / EEO

　　诺华致力于打造一个卓越、包容的工作环境和多元化团队, 代表我们服务的患者和社区。

　　Role Requirements

　　What you'll bring to the role:

　　• Bachelor or higher in Biochemistry, Chemistry or another related science

　　• Fluent in speaking I writing in English

　　• 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

　　Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!

　　You'll Receive: You can find everything you need to know about our benefits and rewards through our Novartis career website.

　　Accessibility and Accommodation:

　　Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please tell your relevant request to our hiring managers.

　　Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, you can follow us via Novartis Group Recruitment WeChat Official Account and Novartis Group WeChat Video Account.

　　Division

　　Operations

　　Business Unit

　　QUALITY

　　Location

　　China

　　Site

　　常熟

　　Company / Legal Entity

　　Novartis Pharma Beijing

　　Job Type

　　全职

　　Employment Type

　　正式员工

　　Shift Work

　　否