Primary Responsibilities:
- Independently lead internal audits and GxP activities, including site and vendor audits, while supporting external audits and regulatory inspections.
- Manage quality issue and CAPA processes, conducting root cause analysis and effectiveness checks to ensure compliance and continuous improvement.
Quality and Compliance:
- Ensure adherence to regulatory guidelines such as 21 CFR Part 11 and ICH GCP, reviewing documentation like informed consent forms and source documents.
- Support SOP development, provide training on quality activities, and contribute to RFP/RFI completion and AI project quality consultations.
Organizational Impact:
- Partner across the organization to strengthen inspection readiness and embed a culture where quality is a personal mandate and improvement is expected.
- Utilize technical proficiency in eQMS and software platforms, communicating findings effectively to senior leaders to maintain rigorous clinical research standards.
Care Access
Care Access works to make health better for all by bringing world-class clinical research and health services directly to communities, often facing barriers to care, through hundreds of research locations, mobile clinics, and clinicians worldwide. The company partners with technology and perseverance to reimagine how clinical research reaches the world, building a future of health that is more accessible for everyone.