Quality Associate Director (pharma)
On behalf of a major pharmecutical MNC with significant operations in China, we are seeking a dynamic and experienced Associate Director of Quality to lead and enhance quality operations This pivotal role ensures compliance with global regulatory standards (e.g., FDA, EMA, WHO), drives GMP excellence, and supports the production of high-quality drug products. The ideal candidate will possess deep knowledge in quality systems, manufacturing processes, and laboratory operations, combined with exceptional leadership and cross-functional collaboration skills.
Key Responsibilities:
- Oversee QA and QC operations across manufacturing and packaging lines
- Lead audits, inspections, and regulatory readiness efforts
- Manage deviations, CAPAs, change controls, and risk assessments
- Ensure robust batch record review and product release processes
- Drive continuous improvement in SOPs, documentation, and data integrity
- Support technology transfers, process validation, and equipment qualification
- Mentor quality team members, fostering a culture of compliance and ownership
- Collaborate with manufacturing, R&D, regulatory affairs, and supply chain teams
Requirements:
- Bachelor's or Master's in Pharmacy, Chemistry, or related life science. Engineering background can be considered.
- Minimum 10 years of pharmaceutical quality experience, 3+ years in leadership roles
- In-depth understanding of GMP, QMS, and regulatory expectations
- Strong analytical, communication, and decision-making capabilities
- Ability to communicate effectively in both Mandarin Chinese and English
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