Senior Clinical Quality Oversight Lead - GCP & RBQM

Ctifacts; Covington (KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Ctifacts in Covington, Kentucky, is seeking a Regulatory QA professional with deep GCP and clinical trial operations knowledge. You will guide compliance across regions, develop QA Oversight Plans, and monitor trial KPIs to drive quality improvements.

Responsibilities include supporting regulatory inspections, training trial teams, and mentoring junior staff, with a focus on RBQM-aligned risk management. Strong English skills required.

Qualifications

• 5+ years of experience in life sciences, CRO, or similar.
• Advanced knowledge of GCP guidelines and clinical trial processes.
• Proficiency in English.
• Auditing certification (RQAP, ASQ) preferred.

Responsibilities

• 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

Skills

Life sciences

GCP

English

Auditing

Job description

Ctifacts in Covington, Kentucky, is seeking a Regulatory QA professional with deep GCP and clinical trial operations knowledge. You will guide compliance across regions, develop QA Oversight Plans, and monitor trial KPIs to drive quality improvements.

Responsibilities include supporting regulatory inspections, training trial teams, and mentoring junior staff, with a focus on RBQM-aligned risk management. Strong English skills required.