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