QA Lead Drug Substance Manufacturing

3 weeks ago

Dundalk, United States WuXi Biologics Full time

QA Lead Drug Substance (DS) Manufacturing - Associate Director A critical role within the QA organisation, the QA Drug Substance (DS) Manufacture Lead will lead the QA team. Responsible for ensuring that biologic drug substance manufacturing is performed in compliance to cGMP, site SOPs and controlled documents from end-to-end, covering warehouse and supply chain management operations, manufacturing operations, batch certification by QP, batch release and shipment for biologics drug substance manufactured in WuXi Biologics Ireland. Organization Description WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We’re one of the world's top three contract development and manufacturing companies for biopharmaceuticals, providing our clients with a world-leading open access technology platform. Your Responsibilities In this role, you will: Lead the QA teams responsible for 24/7 oversight of Warehouse and Supply Chain Management (SCM), Drug Substance Manufacturing Operations and the QA team responsible for batch disposition operations. Develop, implement, and monitor the quality systems relating to warehouse, SCM and manufacturing and batch disposition operations. Provide QA review and approval of SOPs, master batch records, quality risk assessments, change controls and other documentation, as applicable, associated with Manufacturing, Warehouse, SCM and batch disposition operations. Review and approve deviation reports, CAPAs, and technical documents to support GMP decisions and batch disposition. Ensure online QA presence in Warehouse and Manufacturing areas during operation, as required. Lead the GMP Release program. Liaise with internal and external teams to ensure that all deviations, investigations, and batch record review comments are adequately addressed and closed out in a timely manner. Ensure timely and efficient disposition of biologics drug substance batches. Supervise direct reports, provide training and communications, assignment, and prioritisation of work. Manage performance, delivery of objectives and career development of direct reports. Support inspection/audit readiness activities, act as SME for QA DS function during regulatory inspections and Client audits. Lead and/or represent QA on multidisciplinary teams including New Product Introduction (NPI), Technology Transfer and continual improvement projects. Identify and drive opportunities for continuous improvement. Perform all duties in accordance with GMP requirements, SOPs and controlled documents. Your Profile The ideal candidate for this position will have the following: Education: A Bachelor’s degree in a technical discipline (e.g., biochemistry, chemistry, engineering) would be an advantage. Knowledge/Experience Required: 8 plus years’ experience in the biotechnology and/or pharmaceutical industries within a Quality role, preferably in QA or similar. Experience managing a QA operations team would be an advantage. Demonstrated knowledge of Quality Management System and continuous/process improvement tools. Personal skills Strong technical aptitude and knowledge of cGxP requirements and regulations. Excellent interpersonal and communication skills. Proactive attitude with excellent attention to detail. Other Requirements There may be a requirement for occasional travel to locations within Ireland and overseas to support business needs. WuXi Biologics is an equal opportunities employer. Apply now #J-18808-Ljbffr

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