QA Lead Manager (Beijing/Shanghai/Guangzhou)

Summary of Responsibilities:

• Quality Issue Management - provide QA support and oversight by collaboration with business functions to conduct thorough investigations and ensure appropriate CAPAs are identified, developed, implemented effectively.
• Support development of CAPA plans arising from internal audits, sponsor audits, and regulatory inspections.
• Maintain up‑to‑date knowledge of GCP regulations and relevant global/local regulatory expectations, and communicate updates to internal teams as needed.
• Provide QA consultation and compliance guidance to study teams and cross‑functional partners.
• Lead or support inspection readiness activities, including training, process walkthroughs, documentation reviews, and risk‑based preparation.
• Provide inspection management support during regulatory inspections
• Facilitate regular meetings with internal teams and sponsors to discuss quality issues, trends, risks, and continuous‑improvement opportunities.
• Contribute to strengthening quality culture, process improvement, and optimization of quality systems and SOPs.

Qualifications (Minimum Required):

• A minimum of a bachelor’s degree in Life Sciences preferred (or equivalent Life Science experience).
• Experience may be substituted for education.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

• 5 years in regulatory environment (experience in GXP roles).
• Strong understanding of QMS and CAPA processes.
• Ability to manage client responsibilities.
• Report and communicates key quality information to Sr. Managers and QA.
• Able to work effectively within a team environment.
• Able to communicate effectively during client meetings
• Knowledge of GCPs/GxPs.

Physical Demands/Work Environment:

• Flexibility in working outside office may be needed to work with global team and clients
• Occasional travel required.

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