Core Responsibilities
- 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.
