Reporting directly to the General Manager, the Quality Managerprovides strategic oversight and leadership to Quality Operations and Quality Client liaisons to ensure project objectives are met to a high-quality standard and according to commitments while ensuring current Good Manufacturing Practices (cGMPs) compliance for manufacturing of biological product, and compliance to Chinese, US and EU regulations, as applicable.
· Develop, sustain and implement procedures, programs and policies that support GMP operations and overall compliance strategy.
· Coordinate and approve the validation and qualification plans.
· Assure GxP operations are executed in compliance with applicable guidelines and regulations through quality risk management.
· Outlines department objectives, identifying continuous and compliance improvement initiatives, monitors progress of deliverables, and provides support to Managers and Associates.
· Accountable for the master and executed batch record review and lot disposition activities to ensure release of lots within compliance with applicable regulatory submissions and prescribed timelines.
· Facilitates Quality support and works closely with other JinWei functional units including Manufacturing, Facilities Engineering, and Pre-Clinical to assess and resolve quality issues with regards to the facility and products manufactured.
· Serve as team leader in critical quality investigations and ensure corrective and/or preventive action plans to resolve potential product quality and compliance issues are appropriately implemented.
· Participates in the Quality Metric review process, assess data for adverse trends, develop solutions and oversee implementation in their respective area.
· Serve as site liaison for external client or regulatory audits, coordinating audit support, performing facility tours, answering questions and resolving issues. Respond to observations to ensure compliance risks are effectively mitigated.
· Strategy reviewer of quality system documents including but not limited to CAPA, change controls, investigations, and deviations.
· Client Quality agreement construction, negotiation, and approval. Oversees Quality Client liaison for hosting routine client audits. This includes coordinating audit support, performing facility tours, answering questions and resolving issues. Respond to observations to ensure compliance risks are effectively mitigated.
· +7 years of experience within a GMP Manufacturing environment (ideally in bioproduction) in Quality Operations.
· Method validation experience is a must.
· Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs) from development through commercial applications.
Location: Shanghai, China