ONE POSITION IS AVAILABLE. LEVEL PLACEMENT WILL BE BASED ON EXPERIENCE AND SKILLS FOR ROLE. THIS ROLE REQUIRES EXPERIENCE IN EXTERNAL SUPPLIER ORGANIZATION CONTRACT MANUFACTURIERS IN ASEPTIC, COMBINATION DRUG/DEVICE PRODUCTS. PREFER CANDIDATES WHO ARE ABLE TO WORK IN BOTH PRINCETON AND EAST HANOVER LOCATIONS.
Responsible for managing quality aspects at external suppliers for Biopharmaceuticals / Pharmaceutical / Devices 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.
• 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 / pharmaceutical products/ devices 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 with 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 input 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.
• 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 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.
• Escalate any issues or instances of instability per the Novartis escalation policy, and initiate any market action that is required. 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.
• Stability reports and APQR’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.
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 QA Lead and The Supplier Relationship Manager 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 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
• Participate in the ES 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 implemented and followed up
• Maintain current knowledge of local and international regulatory and legislative requirements and trends
EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Minimum requirements Education (minimum/desirable): Bachelor or higher in Biochemistry, Chemistry, Microbiology or another related science
Languages: Fluent in speaking / writing in English
• 5-10 years experience in the pharmaceutical industry, with direct experience with Combination Products / Medical Devices / Pharmaceutical / Biopharmaceutical / API products. Experience in QA Operations, production, QC and/or other relevant operational areas, but must include minimally 3 years in QA, and 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