Job Title: Associate Director, Quality Assurance Operations

Department: Quality

Location: Remote China

Associate Director, Quality Assurance Operations

Location: Guangzhou, China

Overview of Role:

The Associate Director of QA Operations will provide quality oversight to the manufacturing activities at our global CMO network. The candidate will be responsible for resolution of queries from QPs to facilitate on time release of clinical and commercial material, and provide QA support in the preparation of quality section of regulatory submissions. The candidate will act as the primary liaison with CMO sites in China on all Quality and compliance issues.

This position will be based in China in or around Guangzhou. Fluency in mandarin is required.

Role and Responsibilities:

• Working closely with CMOs, ensure drug manufacture and testing activities at CMOs are compliant with applicable cGMPs and product registration details.
• Ensure Data integrity standards are maintained
• Provide support to CMOs in the review of deviations, investigations, CAPAs and change controls and ensure these are completed and documented in a compliant manner
• Provide GXP compliance oversight for all CMOs and serve as PIP at CMO
• Act as primary Quality liaison between Summit and the CMOs
• Lead and ensure GMP inspection readiness activities for CMOs
• Review and approve controlled documents, including manufacturing and packaging batch records, validation protocols and technical reports
• Conduct internal audits of departments and processes
• Review existing policies and procedures, and recommend new and enhanced policies that ensure compliance to regulations
• Write, revise, review and/or approve SOPs, controlled documents to ensure compliance with all applicable regulations
• Ensure issues are identified and managed through to resolution in a timely manner and deliverables are met.
• Participate in developing, reporting, reviewing and trending of quality and performance metrics
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Bachelor’s (or higher) degree in chemistry, biochemistry, biotechnology, or other related life sciences discipline
• Minimum of 8+ years’ experience in GMP Quality in the life sciences, pharmaceutical, and/or biotechnology industry
• Biologics experience is essential
• Fluency in mandarin is required
• Experience in sterile manufacturing is preferred
• Experience in providing quality oversight of CMOs
• Strong expertise and experience with GMP manufacturing requirements for clinical and commercial biologics
• Strong knowledge of cGMP regulations
• Experience leading/hosting US and international health authority inspections
• Excellent communication skills both oral and written
• Experience in working independently on multiple programs in a fast-paced environment with and able to balance changing priorities
• Attention to detail, self-motivated with a strong sense of work ethic
• Excellent interpersonal skills and collaborative

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