Responsible for managing quality aspects at external suppliers for Biopharmaceuticals / Pharmaceutical and to ensure that the operational business is in compliance with cGMP, the Quality Assurance Agreement, regulatory requirements and the Novartis Pharma Quality Manual and is conducted according to the relevant SOPs. Responsible for managing quality interface for outbound relationships for Biopharmaceutical Drug Substance manufactured within internal BPO manufacturing sites. Act as permanent deputy of the Quality Head of External Supply - Biologics.
• Lead External Suppliers Qualification process.
• Acts 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 biopharmaceutical products are in compliance with the Novartis Pharma Quality Manual, the effective Quality Agreement that they meet relevant cGMP regulatory requirements and are conducted according to local SOPs.
• Responsible for driving / initiating External Supplier Quality Risk assessments to be carried out for all External Suppliers. Gaps are 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 defined actions and goals.
• Ensure that a valid QA agreement defined in line with the requirements of the Global template is in place which clearly defines cGMP roles and responsibilities between Novartis and the External Supplier, as well as Product details and requirements. Approve Quality Agreement on behalf of the Quality Head of External Supply - Biologics.
• 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. Ensure site readiness for regulatory inspections at External suppliers where appropriate.
• Manage/Approve 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. Ensure all required actions are taken appropriately and in a timely fashion.
• Escalate any issues or instances of instability per the Novartis escalation policy, and initiate any market action that is required. Decide escalation to Senior Management Level (Level 2) and lead Global Quality Assessments and manage filing (FAR/BPDR) accordingly. 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 SOPs from receipt, through to the implementation and closure.
• Responsible for assessing quality trends and driving continuous improvement for processes and product quality performance.
• Is the Quality representative on the Quality Management Review for External Supply, and ensures robust review and escalation of critical quality issues arising within the area of responsibility.
• Stability reports and PQR’s, Ensure that the External Supplier provides the required product review or the data as specified 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. Approve PQR’s on behalf of the Quality Head of External Supply - Biologics.
• Support due diligence activities and provide External Supply QA recommendation (auditing, technical and quality assessments). Act as Key QA contact for ESO Sourcing/Strategy (and/or Business Development & Licensing) for the technologies in use in his QA organization
• Support launches of product in close collaboration with TRD QA. Ensure External Supplier readiness for commercial manufacturing starting from validation activities.
• Support transfer of products in close collaboration with ESO MS&T and with QA from donor site. Ensure External Supplier readiness for commercial manufacturing starting from validation activities.
• Review and approval of validation protocols and reports. Approve definition of Product Quality Attributes.
• Assess and ensure External Supplier readiness for HA inspections (PAI, directed, other).
• Outbound Supply:
• Acts as Single Point of Contact / SPOC with the Third-Party for all quality related activities at BPO manufacturing site
• Provide the quality presence and in-put to Technical meetings with the Third-Party and establish good working relationships with clear communication and defined actions and goals.
• Ensure that the quality aspects of the relationship are managed in accordance with the effective Quality Agreement.
• Facilitate communication between Third-Party and BPO manufacturing site for the timely resolution of significant quality issues (deviations, major change controls, stability failures, etc.). Ensure that the BPO documentation provided to the Third-Party meets the requirements of the effective Quality Agreement.
• Within the organization
• Implement and maintain a local Quality System and Standard Operating Procedures defining all the processes for managing of External suppliers.
• Ensure that the Quality Head of External Supply - Biologics 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 - Participation 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. Monitor Key Performance Indicators and ensure that all parts of the External Supply QA organization are working in a consistent manner against harmonized expectations. Initiate corrective actions when necessary and perform follow-up on resulting measures.
• 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
• Participate in the ES Quality Plan – ensure that all quality issues at External suppliers are included in this plan. Lead specific actions of the Quality Plan.
• Lead/Participate in projects as defined and ensure that all aspects are implemented and followed up
• Able to manage complex products in a cross functional environment (various technologies and multiple interfaces, complex market distribution)
• Personal development and People development
• Maintain current knowledge of local and international regulatory and legislative requirements and trends
• Support development of QA associates with respect to product and process knowledge
• Provide mentoring of junior QA associates
Bachelor or higher in Biochemistry, Chemistry, Microbiology or another related science
• 12 years or more experience in the pharmaceutical industry, with direct experience with Pharmaceutical/Biopharmaceutical/API products. 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
• Strong Technical understanding of pharmaceutical processes
• Team and consensus builder, with definitive and authoritative decision making ability
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