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Cqa

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Randstad

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Location:
China , Shanghai

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Category:
-

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Contract Type:
Not provided

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Salary:

360000.00 - 480000.00 CNY / Year
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Job Responsibility:

  • Develop, implement, and maintain clinical SOPs, policies, work instructions, and templates
  • Ensure SOPs align with global regulatory requirements (e.g., FDA, EMA, ICH GCP, MHRA)
  • Manage SOP lifecycle activities including authorship, review, approval, training, and periodic review
  • Provide QA oversight for clinical trials conducted by CROs, vendors, and investigative sites
  • Support risk-based quality management (RBQM) activities, including quality risk assessments and mitigation plans
  • Review clinical trial documents (e.g., protocols, ICFs, monitoring plans, vendor plans) for quality and compliance
  • Plan, conduct, and manage internal audits, vendor audits, and investigator site audits
  • Support regulatory inspections (e.g., FDA, EMA, MHRA, NMPA), including inspection readiness, hosting, and follow-up
  • Track and manage audit findings, CAPAs, and effectiveness checks
  • Oversee deviation, noncompliance, and issue management processes
  • Ensure timely root cause analysis, CAPA development, implementation, and effectiveness verification
  • Trend quality issues and escalate systemic risks
  • Qualify and oversee CROs and vendors through audits and performance metrics
  • Review quality agreements and ensure clear delineation of responsibilities
  • Monitor vendor compliance with contractual and regulatory requirements
  • Develop and manage GCP and SOP training programs
  • Promote a culture of quality and continuous improvement across clinical teams
  • Provide QA guidance and consultation to cross-functional stakeholders
  • Develop and track quality metrics and KPIs
  • Perform trend analysis to identify risks and improvement opportunities
  • Support inspection readiness and quality management reviews

Requirements:

  • Bachelor's degree or above in life sciences or related fields
  • Master's degree or higher preferred
  • At least 5 years of clinical research experience, including at least 2 years focused on GCP quality assurance/compliance
  • Experience in GCP management (including root cause analysis) and hands-on support for regulatory GCP inspections
  • Proficient in NMPA, FDA, and EMA clinical research regulations and ICH-GCP guidelines
  • familiar with global multi-regional regulatory requirements
  • Ability to independently develop study quality management plans and audit protocols and lead their implementation
  • Excellent communication and coordination skills, capable of building effective internal and external partnerships and guiding clinical teams to focus on quality
  • Adaptable to a fast-paced, multi-tasking, and dynamic startup environment, able to meet tight deadlines
  • Fluent in English, capable of using it as a working language

Additional Information:

Job Posted:
March 26, 2026

Expiration:
June 03, 2026

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