Director of Quality Assurance

19 hours ago

Hsinchu City, Taiwan Synmosa Biopharma Corporation Full time NT$1,800,000 - NT$2,500,000 per year

  1. Lead the establishment, maintenance, and continuous improvement of the GMP Quality Management System in compliance with PIC/S GMP, FDA, ICH, and other global regulations.

  2. Develop, implement, and review QA policies, SOPs, and quality standards to ensure regulatory compliance.

  3. Oversee deviation management, CAPA, change control, risk assessments, and management review meetings.

  4. Plan and execute internal audits and supplier audits to ensure supply chain quality compliance.

  5. Collaborate closely with Production, QC, R&D, and Regulatory Affairs to support product development, technology transfer, and commercialization.

  6. Lead, mentor, and develop the QA team to build strong compliance culture and capabilities.

  7. Act as the primary contact with regulatory authorities (TFDA, US FDA, EMA, etc.) during inspections and regulatory communications.

  8. As a senior leadership team member, the QA Director is accountable for defining quality strategy, ensuring global regulatory compliance, and safeguarding product quality and patient safety across all manufacturing operations.

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