ESSENTIAL FUNCTIONS- Maintain advanced knowledge of ICH GCP compliance and regulatory expectations across multiple regions
- Provide regulatory compliance guidance and quality improvement consult to internal and external customers, ensuring global alignment
- Conduct protocol risk reviews and develop trial level QA Oversight Plans aligned with RBQM principles, trial phase, and identified critical-to-quality (CtQ) cross-functional risks
- Monitor trial-level QTLs, KPIs, and communicate results to the trial team
- Conduct TMF and CTQ risk-based SOP compliance assessments and targeted deep-dive evaluations based on identified quality signals and trends
- Communicate compliance assessment outcomes clearly and effectively, verbally and in writing, escalating significant compliance risks to project team leadership, QA leadership, CTI executive management, and sponsor representatives as appropriate
- Design and deliver advanced training to trial teams on QA topics tailored to address compliance challenges identified during snapshot and deep dive compliance assessments, audits, and inspections
- Independent trend analysis of quality events and protocol deviations, separate from the trial team review, to detect emerging or unrecognized trends
- Review Major/Critical CAPAs and provide strategic guidance for action implementation, and monitor effectiveness checks
- Attend Project Management-led team meetings
- Lead or attend Client QA to QA governance touchpoint meetings
- Participate in regulatory inspections and mock inspections to support inspection readiness
- Work with CTI internal auditing function to target trial-specific CTQ processes for the internal audit schedule, as applicable
- Review RBQM risks when applicable for completeness and inspection readiness
- Maintain continuous inspection readiness through alignment of global pre-inspection requests with controlled quality documentation
- Develop and implement periodic sponsor questionnaires to measure overall approval, satisfaction, and perceptions of program effectiveness
- Host sponsor qualification and requalification audits
- Mentor and lead junior-level employees as assigned
REQUIRED EDUCATION AND EXPERIENCE- Bachelor's degree or equivalent relevant experience
- 5+ years of experience in life sciences, CRO, or similar industry
- Advanced knowledge of GCP guidelines, clinical trial operations, and core clinical research processes.
- Proficiency in the English language
- Certification in auditing (RQAP, ASQ) or other quality-related certification is preferred
Important NoteIn light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an
@ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.
Please Note - We will never communicate directly with you via Microsoft Teams Messaging or by text message
- We will never ask for your bank account information at any point during the recruitment process
