Head of Quality Assurance Shared Services Center

Key Responsibilities

Product Project Management

• Lead and/or review RFIs (Request for Information) and RFPs (Request for Protocol) from a quality perspective.
• Lead the completion of quality questionnaires.
• Review and approve Quality Assurance Agreements (QAAs).
• Participate in regular project meetings and engage in quality-related discussions with clients, when necessary.

Related Quality Project Management (Corporate and Probio)

• Coordinate and facilitate projects to align with expected timelines and plans.
• Summarize and report project progress regularly.
• Participate in meetings and provide recommendations from a quality perspective.

Validation Management

• Lead the development of the Validation Master Plan (VMP).
• Allocate and manage resources to complete validation/qualification activities according to plan (including equipment qualification, cleaning validation, and APS).
• Coordinate cross-functional teams to support CSV, analytical method validation, and facility and utility qualifications.
• Support Level A/B projects from a validation standpoint.
• Review and approve validation protocols and reports.
• Review and approve validation-related procedures and SOPs.

Non-GMP Quality Management

• Establish and optimize the quality system during Non-GMP phases (R&D and PD), balancing compliance and operational efficiency.
• Review and approve Non-GMP procedures and SOPs.
• Review and approve development protocols and reports, as needed.
• Lead the team to perform shop floor monitoring, Data Integrity (DI) checks, and training management to meet regulatory requirements.

Document and Training Management

• Establish and continuously optimize document management procedures that meet regulatory requirements, covering the entire document lifecycle: drafting, revision, review, approval, replacement/withdrawal, storage, and destruction.
• Lead the personnel training and qualification programs.

Qualification & Requirements

Knowledge and Skills

• Strong familiarity with international and Chinese GMP regulations and guidelines.
• Extensive experience in clinical and commercial quality system management and validation management.
• Experience in Cell and Gene Therapy (CGT) and antibody manufacturing.
• Proven experience in project management.
• Proficient in English.

Education Background

• Bachelor’s degree or higher in Pharmaceutical Engineering, Pharmaceutical Preparation, Biology, Chemistry, or related disciplines.

Working Experience

• Over 10 years of experience in quality management or validation management within pharmaceutical companies or biopharmaceutical CDMOs.
• Experience with aseptic product production quality management or GMP facility construction is preferred.

Other Requirements

• Strong learning agility.
• Excellent communication, project management, and stress management skills.
• Effective team player.

Benefits

• Insurance Benefits
• Retirement Benefits
• Vacation Policy
• Other Perks and Benefits…