QA Manager / Associate Manager (Compliance & Supplier Management)

About the role

A client in the pharmaceutical industry in Taiwan is looking for an experienced QA Associate Manager or Manager (Compliance/Supplier Management). The role oversees the quality of CDMO projects and ensures site compliance, with a focus on supplier management. You will manage supplier qualification, ensure regulatory compliance and drive continuous improvement in the pharmaceutical manufacturing facility.

Key responsibilities

• Provide quality oversight of CDMO project activities, including review and approval of documentation and change controls for trial and submission batches.
• Manage supplier qualification and audit programs so that raw materials meet global standards, and regularly review the Approved Supplier List.
• Lead and coordinate internal and external audits, including audit readiness and follow-up for regulatory inspections (FDA, TFDA) and sponsor/customer audits.
• Maintain site self-inspection programs and drive continuous improvement initiatives.
• Ensure Quality Assurance Agreements (QAAs) support CDMO operations.
• Report site quality metrics through scorecards and run quality councils.
• Oversee annual cGMP refresher training and periodic GEMBA walks, and align personnel training with job roles.

Required profile

• Bachelor's degree or above in Chemistry, Bio Sciences, Life Sciences, Pharmacy or Chemical Engineering.
• At least 5 years in a supervisory QA compliance role in pharmaceutical CDMO manufacturing and/or medical devices.
• Fluent spoken and written Mandarin and English.
• Relevant GMP and ISO training or certification; auditor or lead auditor for pharmaceutical quality systems or ISO 13485.

Required skills

• Quality compliance, supplier and audit management.
• Strong understanding of cGMP and use of investigation tools for root cause analysis.
• Critical thinking, continuous improvement mindset and strong work ethics.