Responsibilities
- Provide independent GCP quality oversight for ongoing Phase IIb/III clinical trials.
- Review study documentation for compliance with:
- ICH-GCP
- FDA regulations (21 CFR Parts 11, 50, 54, 56, 312)
- Internal SOPs and quality standards
- Assess protocol deviations, quality trends, and study-level risk indicators.
- Conduct remote GCP audits, including:
- CRO/vendor audits
- TMF quality reviews
- Process audits
- Support FDA inspection readiness activities, including:
- Gap assessments
- Mock inspection preparation
- CAPA review and effectiveness checks
- Track and trend audit findings.
- Evaluate CRO quality systems and oversight documentation.
- Review vendor audit reports and ensure appropriate follow-up.
- Provide quality input into vendor governance processes.
- Partner with Clinical Operations and functional leads to:
- Identify emerging quality risks
- Assess mitigation strategies
- Ensure documentation supports inspection readiness
- Support development and refinement of quality metrics and KPIs.
- Prepare clear, concise audit reports.
- Develop executive summaries and quality trend reports.
- Maintain quality documentation tracking tools.
Requirements
- Bachelor’s degree in Life Sciences or related field.
- Minimum 5+ years of Clinical QA experience.
- Demonstrated experience supporting late-phase (Phase IIb/III) clinical trials in the U.S..
- Strong working knowledge of: ICH-GCP, FDA regulatory framework, Risk-based quality management principles
- Experience conducting GCP audits (site, process, and/or vendor).
- Prior involvement in FDA inspection readiness activities.
- Strong documentation and report-writing skills.
- Ability to work independently in a fully remote environment.
Nice to Have
- Experience in metabolic, endocrinology, or obesity programs.
- Exposure to GLP-1 receptor agonist development programs.
- Experience in large, multi-site U.S. trials.
- Experience working within sponsor oversight or FSP environments.
- Quality certification (e.g., CQA, RAC)
Additional Information
- Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
