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中國其他地區, 北京, 臨床及註冊 | 2021-10-04

Sr. Manager / Manager, GCP auditor

Job Title: Sr. Manager / Manager, GCP auditor
Location: Beijing/Guangzhou

Summary of Relevant Job Responsibilities

  • Contribute to Quality and Risk Management Framework / Program across C&R.
  • Drive continuous improvement for Clinical Trials Quality.
  • Manage/support GCP inspections relating to clinical research activities.
  • Support management in the resolution of quality related issues.

Major Responsibilities Duties

  • Risk assessment and quality oversight plan
    • Collaborates with the line functions within C&R, to perform risk assessments and identify key data/procedures and high risk areas.
    • Proactively analyses quality data and leverages quality indicators to identify potential trends and risks.
    • In alignment with risk assessments, contributes to the QA strategy and quality oversight plan.
    • Supports the identification of audit substrate for scheduling as appropriate.
  • Audit
    • Prepares, conducts QA audits, generates audit reports on time, communicates results to relevant stakeholders (e.g. Vendors/Clinical Operations).
    • Interacts with various teams to ensure proper root cause analysis is performed and corrective and preventative actions are developed and approved.
    • Tracks corrective and preventative actions and bring QA observations to closure as applicable.
  • GCP quality expert
    • Serves as member of project team through participation in the applicable meetings, providing GCP compliance advice and guidance, to achieve continuous quality improvement in HMP.
    • Support Significant Quality Issues management, including perform root cause analyses, review remediation (corrective and preventative actions).
    • Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation.
  • Inspection management
    • Provide inspection readiness and management support as appropriate.
    • Develops and delivers awareness training internally and externally.
    • Develops and shares lessons leant after inspection with relevant stakeholders.
  • QA optimization
    • Participates in the development/enhancement of QA procedures, guidance documents and audit tools to ensure continues improvement.
    • Promotes standardization of auditing approach within QA.
    • Routinely suggests new audit techniques/aids in areas of technical expertise.
    • Provides training and mentorship to less experienced members of QA staff.
    • Contributes to build the work climate/culture within QA function, exemplifies the leadership behaviors.

Position Qualifications & Requirements

  • Minimum bachelor’s degree in clinical medicine or Life/Biological Sciences, advanced degree preferred.
  • Experience in clinical research (min. 5 years) & quality management/ quality control (min. 3 years).
  • Experience in risk assessment and mitigation planning.
  • Good at English writing and speaking.

If interested, please forward your resume to