Associate Director, Product Lifecycle Quality

AveXis in Nixa, MO

  • Industry: Executive Management - Engineering/Production
  • Type: Full Time
position filled
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Associate Director, Product Lifecycle Quality is responsible for the holistic product quality stewardship of assigned AveXis gene therapies across multiple sites (including CMOs) throughout the product lifecycle, from late phase development to discontinuation. Responsibilities Accountable for end-to-end quality stewardship of assigned AveXis gene therapy product(s) from late phase development to discontinuation. Accountable for the end-to-end product quality strategy across the global network and drive continual improvement through product and process lifecycle management, represent Global QA Ops in cross-functional project life cycle team. Provide expert quality guidance, technical support and quality leadership for implementation of quality guidelines, regulations, standards, processes, and strategy for assigned product(s) throughout the product and process lifecycle. Maintain global Quality oversight, oversee global regulatory filing activities including product registration and variation management, of assigned AveXis gene therapy product(s). Act as global quality lead in product related Q escalations, recalls and BPDR handling for product specific quality and compliance challenges. Provide clear direction and drive efficient decision making for global Quality issues related to assigned products. Involved in major product relevant investigations, in particular multi-sites deviations and recurring deviations, by leading / supporting global investigations / Task Force at the sites. Support global site readiness for product pre-approval inspections across the AveXis network. Maintain global quality oversight on Product Launch, Supply Chain, and Technology Transfers. Bridge between clinical, development and technical operation teams and engages at multiple interface(s) between the organizations to functionally lead and drive robust execution of the defined Product related Quality Program. Actively drive network wide Quality strategy harmonization and promote product Quality as competitive advantage. Support AveXis Global Quality Assurance Operations for late phase projects as required. Qualifications Bachelor degree required; MSc / PhD in Biochemistry, Pharmacy, Chemistry, Microbiology or another related science preferred. Minimum 15 years' experience in an operational GxP area, in Manufacturing, Development or QA. Natural Sciences, or related experience. Knowledge in biology/chemistry, pharmacy and biotechnology, medical devices/combination products. Thorough knowledge and expertise in cGMP and applicable guidelines. Sound scientific, technical and regulatory knowledge, ideally in Biotechnology; expertise in validation (process and cleaning) a plus. Excellent and proven ability to analyze and evaluate GMP compliance. Proven ability to influence people and communicate in a process-oriented organization. Excellent organizational and management skills. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.
Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality

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