Head of Quality (Chengdu, China)
Key Responsibilities
Lead the development, implementation, and continuous improvement of the company’s quality management system.
Ensure compliance with GMP and cGMP standards and regulatory requirements.
Oversee all quality-related activities across QA, QC, and Validation functions.
Establish and maintain quality management procedures, production control procedures, and standard operating procedures (SOPs).
Approve all quality-related changes and manage deviations, complaints, and adverse event investigations.
Oversee qualification and validation activities, including review and approval of protocols and reports.
Evaluate and approve materials and manage supplier quality performance.
Establish and maintain a robust quality training system, ensuring all relevant personnel receive appropriate initial and ongoing training.
Collaborate cross-functionally to support continuous improvement and inspection readiness.
Qualifications
Education:
Bachelor’s degree or higher in Pharmacy, Biomedical Science, or related field
Experience:
10+ years of experience in pharmaceutical production and quality management, including at least 5 years in commercial-scale operations
Proven experience leading GMP certification projects (FDA or EU certification preferred)
Skills & Competencies:
Deep understanding of pharmaceutical regulations and quality systems
Excellent leadership, communication, and cross-functional collaboration skills
Strong analytical and decision-making abilities
Proficient in Microsoft Office (Word, Excel, PowerPoint)
Fluent in English and Mandarin (spoken and written)
5+ years of people management experience