QA Manager/ Associate Manager (Compliance/Supplier Management)

We are working with a client in the pharmaceutical industry in Taiwan. Our client is looking for an experienced QA Associate Manager/Manager (Compliance/Supplier Management) who will be responsible for the quality oversight of CDMO projects and ensuring site compliance, particularly focusing on supplier management. In this role, you will manage supplier qualification, ensure regulatory compliance, and drive continuous improvement in the pharmaceutical manufacturing facility.

Location: Taiwan

Job Responsibilities:

• Provide quality oversight on CDMO project activities, including review and approval of documentation and change controls for trial and submission batches.
• Manage supplier qualification and audit programs to ensure raw materials are produced in compliance with global standards.
• Regularly review Approved Supplier List to ensure alignment with current compliance standards.
• Lead and coordinate internal and external audit activities, including audit readiness and follow-up for regulatory inspections (FDA, TFDA) and sponsor/customer audits.
• Implement and maintain site self-inspection programs and drive continuous improvement initiatives.
• Establish and ensure current Quality Assurance Agreements (QAAs) support CDMO operations.
• Coordinate and report site quality metrics through site scorecards and facilitate quality councils.
• Oversee annual cGMP refresher training and organize periodic GEMBA walks to promote compliance with FDA and TFDA standards.
• Ensure personnel training and qualification programs are aligned with job roles and responsibilities.

Job Requirements:

• Bachelor’s degree or above in Chemistry, Bio Sciences, Life Sciences, Pharmacy, or Chemical Engineering.
• Minimum 5 years of experience in a supervisory QA Compliance role within pharmaceutical CDMO manufacturing operations and/or medical devices industry.
• Proficiency in quality compliance functions, including supplier and audit management.
• Strong understanding of cGMP principles and experience using investigation tools for root cause analysis.
• Proficiency in both Mandarin and English, spoken and written.
• Relevant training or certification in GMP and ISO standards.
• Auditor or Lead Auditor for Pharmaceutical Quality Management Systems or ISO 13485.
• Demonstrated critical thinking, continuous improvement mindset, and strong work ethics.