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Head of Quality

2 weeks ago

Chengdu, Sichuan, China Systimmune Full time CN¥150,000 - CN¥250,000 per year
We are seeking an experienced Head of Quality to lead our company's pharmaceutical quality management function. This role is responsible for establishing, improving, and maintaining a robust GMP-compliant Quality Management System (QMS) to ensure product quality, regulatory compliance, and operational excellence across the organization.
 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