Manager, Clinical Quality Oversight

CTI Clinical Trial and Consulting Services; Covington (KY); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Hybrid work from home opportunities

Health benefits

Tuition reimbursement

Paid time off

Job summary

CTI Clinical Trial and Consulting Services in Covington, KY seeks an experienced QA/regulatory compliance professional to ensure GCP compliance across regions. You will lead quality improvements for internal and external customers and develop QA Oversight Plans aligned with RBQM principles.

The role requires Bachelor’s degree and 5+ years in life sciences; strong English and auditing certifications are preferred. You will mentor junior staff and support regulatory inspections.

Qualifications

• 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.
• Auditing certification in RQAP, ASQ, or similar is preferred.

Responsibilities

• Maintain knowledge of ICH GCP compliance and regulatory expectations across 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

GCP knowledge

Regulatory compliance

Quality improvement

English proficiency

Education

Bachelor’s degree or equivalent relevant experience

Advanced degree in life sciences or related field (preferred)

Job description

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

Why CTI?

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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