Associate Director, Supplier Quality Assurance

About the role

The Associate Director, Supplier Quality Assurance provides strategic oversight of global API suppliers, ensuring compliance with cGMP, company standards and international regulations. The role safeguards product integrity and patient safety across manufacturing, packaging, testing and distribution while operating in a virtual, matrixed environment.

Key responsibilities

• Serve as the primary Quality liaison for strategic API suppliers, maintaining compliance with GMP, EU, FDA and Annex 1 requirements.
• Negotiate and maintain Quality Agreements aligned with Commercial Agreements.
• Plan and lead on‑site or remote audits, issue evidence‑based reports and drive effective CAPA.
• Strengthen supplier Quality Management Systems, including change control, deviations, CAPA, OOS/OOT investigations and document control.
• Review and approve supplier change controls, coordinating regulatory impact assessments.
• Lead investigations into deviations, microbiological excursions, stability issues and complaints.
• Support technology transfers and process validation to ensure compliant product realization.
• Monitor supplier performance via KPIs, identify trends and implement systemic corrective actions.

Required profile

• Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering or related field.
• 8+ years experience in GMP‑regulated environments (API and/or drug product) with responsibility for Quality Assurance/Control.
• Strong knowledge of EU, FDA and global regulations, ICH guidelines and Annex 1.
• Proven ability to lead root‑cause analyses, CAPA and regulatory reporting.
• Fluent in English and able to communicate effectively in Chinese.
• Willingness to travel approximately 25% domestically and internationally.

Required skills

• cGMP regulatory expertise (EU, FDA, ICH, Annex 1).
• Quality Management System (QMS) elements: change control, deviations, CAPA, OOS/OOT investigations.
• Electronic QMS/LIMS tools such as TrackWise.
• Advanced Excel and data analysis for KPI trending.
• Root‑cause analysis and corrective action implementation.
• Technology transfer and process validation support.