『保瑞-中壢廠』QA Associate Manager/Manager(Compliance/Supplier Mgt)

Job Summary: 1.Provide QA oversight CDMO Projects and Site compliance activities with quality oversight for commercial batches. 2.Achieve QA department goals and company objectives. Job Duties and Responsibilities: 1.CDMO Projects - Quality oversight on quality activities including review and approve documentation, change controls for trial/submission batches. 2.Supplier Management - Manages Supplier Qualification, Audit program and Approved Supplier List 3.Audit Management - Manages internal and external audit activities, reviews and supports site audit readiness strategy, oversees preparedness for audits from agency (FDA, TFDA), or external audits from the sponsors/customers, support regulatory actions follow-ups on audit non-conformance resolutions and CAPA follow-ups. 4.To provide oversight for site self-inspection programs and implement continuous improvement initiatives. 5.Management of Quality Assurance Agreements (QAAs) – Establish and ensure current QAAs is up-to-date to support CDMO operations. 6.Site Score cards Management – Coordinate and report site quality metrics and organize quality councils 7.Oversight on annual CGMPs refresher training, coordinate periodic GEMBA walks and support site QIP programs to ensure site compliant to current FDA CFRs, TFDA regulations and customers requirement per Quality Assurance Agreements established for CDMO activities 8.Ensure personnel training/ qualification and curriculum are aligned to job roles and responsibilities 9.Others: Any additional assignment requested by Supervisor.