Site QC Head

Job Description Summary At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for an experienced Quality Control Leader with previous experience in pharmaceuticals, diagnostics and/or medical device to help us reach our ambitious goals. As the Site QC Head, you will lead the Millburn Quality Control organization, including release and in-process testing, environmental monitoring and sterility assurance, stability testing, lab investigations, and analytical science and technology. This role reports to the Millburn Site Quality Head. Key responsibilities: Lead the Millburn Site QC function, about 40 associates, and manage resource allocation to ensure timelines and key milestones are met. Develop and strengthen the Quality Culture within the Quality Control organization. Ensure associates have development plans and identify opportunities for growth. Ensure quality systems for Quality Control, Environmental Monitoring, Stability, Analytical Science and Technology meet all applicable Health Authority regulations, guidelines, etc. Set and manage department objectives and performance. Develop and monitor KPIs across the organization, including cycle time, reliability, RFT, etc. Identify and lead continuous improvement activities. Evaluate impact and anticipate implications of important emerging regulatory requirements, industry trends and external regulatory actions associated with Quality Control, Environmental Monitoring, Stability, Analytical Science and Technology. Collaborate through effective relationships and partnership with External Relations for the ongoing monitoring of emerging regulations, and where appropriate, participate in / collaborate with external working groups. Develop and implement strategies, processes and plans for inspection readiness. Represent Quality Control during internal and external inspections. Ensure adequate management of QC related validations, transfers, investigations related activities (deviations, OOS, OOE, OOT, CAPAs, trending), and Change Controls. Procure site validation and qualification support, support site launches of manufacturing products. Ensure and maintain qualified status of lab equipment and methods for intended use in QC laboratories. Participate in the preparation and consolidation of the Quality Control organization’s budget. Essential Requirements: BSc in Chemistry, Biology, Pharmacy, Biotechnology, Biomedical Engineering, or related experience. Advanced Degree is preferred. 10+ years’ experience in Quality Control, Quality Assurance, Quality Systems, Quality / Regulatory Compliance, Operational GxP area(s) (Manufacturing / Development), Supplier Quality and / or Post Market Quality within the pharmaceutical, diagnostic and / or medical device industries including prior experience with aseptic manufacturing. Experience in advanced therapies (Cell and Gene Therapy, Radioligand Therapy, etc.) is preferred. 5+ years’ experience leading and developing people. Experience developing high performing teams and talent management. Experience leading leaders is preferred. Must have a working knowledge of FDA and ex-USA regulatory requirements as well as industry quality management tools, standard, and quality systems. Understanding of United States Pharmacopeia (USP), European Pharmacopeia (EP), American Chemical Society (ACS). In-depth knowledge of cGMP, applicable FDA Regulations (e.g., 21 CFR 4, 7, 11, 210, 211, 212), ICH Guidelines, EU Pharmaceutical Regulations and Directives, ISO Standards, etc. Prior experience with Health Authority Audits / Inspections, including, front room and response to findings / observations. Must have an understanding of pharmaceutical industry trends and practices. Broad cGMP experience is required with knowledge and understanding of manufacturing, quality control, and validation requirements and activities. Prior / advanced experience within microbiology, environmental monitoring, sterility assurance is preferred. Desirable Requirements: Prior experience in a global, matrix organization Experience in process improvement approaches (e.g., Lean, Six Sigma, 5s) and leading projects Benefits and Rewards:

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