The Quality Assurance Manager of Combination Products will be responsible for providing quality oversight of Novartis suppliers and support for Novartis' combination product development efforts throughout clinical development, product registration, commercialization, and lifecycle management.
This position is also responsible for overseeing the Compliance, Sterile Operations group which includes directing the Third Party Compliance Managers and Associates to ensure GMP compliance for all contracted and purchased third party sterile products. This position must provide direct quality leadership for all business critical BD&L projects. The Associate Director coaches the Third Party Compliance Managers and Associates to ensure correct interpretation of Regulatory requirements and works directly with the External Supply Chain and Compliance Managers and Associates to resolve quality issues with Third Party partners. This position will define and improve the Third Party Compliance program, process and policies. The position is also responsible for performing due diligence visits for new and proposed third party partners to assess overall GMP compliance and participating in site inspections/audits as needed. The Associate Director acts as a senior quality representative for the organization when interacting with sterile contract service providers and is ultimately responsible for the quality decisions made by the Compliance Managers and Associates.
Manages the operations and activities of compliance, sterile manufacturing operations area. Establishment and management of performance metrics for sterile manufacturing operations area including KQI's and KPI's. Set and monitor compliance management policies for sterile operations.Utilize regulatory compliance knowledge and risk assessment capability to guide the Third Party Compliance Managers and Associates Direct the resolution of critical compliance issues related to sterile third party manufactures and contractors.Establish, review and approve Quality Agreements.Review Supply Agreements to assure quality matters are adequately and accurately addressed.Review and approve audit reports and confirms the auditee's approval status.Coach the Compliance Managers and Associates in conducting risk-based quality assessments and risk-based decisions for supplier/service provider quality issues.Lead site audits/inspections and due diligence visitsInterfaces with Supply Chain Management to ensure supplier statuses are made visible and support business needs while maintaining compliance for suppliers. Manages/interacts with cross functional groups across multiple sites as needed. Negotiate and exchange information with all levels of management. Requires the ability to influence others to achieve results. Picks, trains, mentors and develops staff. Oversee performance management system for all direct reports including goal setting, performance reviews, salary reviews & recommendations. Performs other duties as assigned. Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HSE, etc.)
Responsible for managing quality aspects at external suppliers for Biopharmaceuticals / Pharmaceutical / Medical 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.
Role can be based in Princeton NJ or East Hanover NJ.
Minimum BA or BS degree required, preferably in a life science-related field such as Biology, Chemistry, Pharmacy etc. MA or MS degree preferred. English Minimum 10 years of Pharmaceutical experience (must include some Quality/Compliance/Regulatory experience). Experience in internal and external GxP auditing. Must have at least 5 years of supervisory/management experience. Experience working in and leading cross-functional teams. Preferred experience participating in or managing quality systems & processes. Capable of routine domestic and occasional global travel, approximately 35% of time. Required knowledge of FDA GxP regulations for sterile and non-sterile products with preferred additional knowledge of EMEA/WHO GxP regulations. Experience in Medical Device Quality.