Qa Lead Drug Substance Manufacturing

Company description: Wu Xi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries.
Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide.
The company has sites/offices in China, US, EU and company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies.
Job description: 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 c GMP, 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 Wu Xi Biologics Ireland.
Organization Description Wu Xi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries.
Were one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform.
We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing.
Department Description As QA DS Manufacture Lead, youll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives.
In this role youll be reporting to the Director of Quality, Wu Xi Biologics.
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, as appropriate, to ensure that all deviations, investigations, and batch record review comments are adequately addressed and closed out in a timely manner as defined in SOPs.
Liaise with internal and external teams, as appropriate, to ensure that all CAPAs, change controls, internal audit observations are addressed and closed out in the required time frame.
Ensure timely and efficient disposition of biologics drug substance batches.
Supervise direct reports on a day-to-day basis, provide training and communications, assignment, and prioritisation of work.
Manage performance, delivery of objectives and career development of direct reports.
Ensure clear communication on issues and timely escalation as applicable.
Support inspection/audit readiness activities, act as SME for QA DS function during regulatory inspections and Client audits, prepare responses to observations, monitor implementation of follow-up actions.
Lead and/or represent QA on multidisciplinary teams including New Product Introduction (NPI), Technology