品保部 Clinical QA Sr. Specialist / Supervisor / Manager

The Manager serves as the key technical resource and Good Clinical Practice (GCP) subject matter expert for clinical study execution functions and provides independent, strategic, risk-based quality oversight of clinical development activities. The role supports compliance with applicable regulations, ICH GCP, company procedures and quality standards, with a focus on protection of trial participants and the reliability and integrity of clinical trial data and results.

Job Description

• Provide independent GCP quality consultation and interpretation on regulations, standards, and quality systems to clinical study execution teams.
• Partner with operational teams to develop and execute risk-based quality and audit plans, ensuring audits are completed and reviewing subsequent CAPA plans.
• Identify, communicate, and mitigate study/program quality risks in a timely manner by participating in risk management forums.
• Develop and execute inspection preparedness strategies, participating in inspection activities from preparation through response execution.
• Conduct directed or for-cause audits, and oversee and approve quality event investigations and CAPAs.
• Represent Quality in study management forums, governance teams, and interdepartmental process improvement initiatives.
• Provide regular study and program status updates to Quality Leadership and senior stakeholders, offering expertise at management review meetings.
• Participate in evaluating and selecting GCP service providers.
• Monitor departmental metrics and key quality indicators to optimize SOPs and work instructions.
• Mentor junior staff, with potential progression into direct people management responsibilities.
• Host and support audit and inspection preparation; and lead CAPA/response follow-up.