We are seeking an experienced Clinical Research Quality Assurance (QA) Auditor with strong FDA audit experience to support ongoing and upcoming clinical research activities. This contract role will focus on ensuring compliance with FDA regulations, GCP guidelines, and internal SOPs across clinical trials and associated processes.
Key Responsibilities:
- Conduct internal and external audits of clinical trials, vendors, and systems to ensure compliance with FDA regulations, ICH-GCP, and company SOPs.
- Prepare, execute, and document audit plans, reports, and follow-up activities.
- Assess clinical sites, CROs, and vendors for regulatory compliance and data integrity.
- Identify gaps, risks, and areas for improvement; provide actionable recommendations.
- Support inspection readiness activities and participate in FDA inspections as needed.
- Review CAPAs for adequacy, implementation, and effectiveness.
- Collaborate cross-functionally with clinical operations, regulatory, and quality teams.
- Maintain audit documentation and ensure timely reporting of findings.
Qualifications:
- Bachelor’s degree in life sciences, nursing, or related field (advanced degree preferred).
- Minimum 5+ years of QA auditing experience in clinical research.
- Demonstrated experience with FDA inspections and audit processes.
- Strong knowledge of ICH-GCP, FDA regulations (21 CFR Parts 11, 50, 54, 56, 312), and industry standards.
- Experience auditing clinical sites, CROs, and vendors.
- Excellent analytical, documentation, and communication skills.
- Ability to work independently and manage multiple priorities in a contract environment.
Preferred Qualifications:
- Lead auditor certification or equivalent QA certification.
- Experience supporting inspection readiness for regulatory authorities.
- Background in biotech, pharma, or CRO environments.