Posted on: Wed 16-09-2026

Afro-Reach Clinical Research Organization (Afro-Reach CRO) is a clinical research organization dedicated to delivering high-quality clinical research and regulatory solutions. We support clinical trials through strong operational execution, regulatory compliance, and collaboration with sponsors and research partners, contributing to the advancement of healthcare and improved patient outcomes.

We are  recruiting to fill the position below:

Job Title: Director, Clinical Quality & GCP Compliance

Location: Wuse Zone 5, Abuja (FCT)

Employment Type: Full-time 

 

Position Summary

• The Director, Clinical Quality & GCP Compliance serves as ARO's functional lead for Clinical Quality Assurance and GCP compliance and is responsible for the day-to-day leadership, management, and oversight of the Quality function in Nigeria and across applicable ARO-supported programs.
• The Director provides independent, risk-based quality oversight to ensure clinical research activities, organizational processes, vendors, and programs are conducted in accordance with applicable ICH Good Clinical Practice (GCP), National Agency for Food and Drug Administration and Control (NAFDAC) requirements and guidance, applicable Nigerian research ethics requirements including National Health Research Ethics Committee (NHREC) requirements, sponsor obligations, contractual commitments, and ARO policies and Standard Operating Procedures (SOPs).
• The Director is accountable for routine leadership and execution of the Clinical Quality/GCP function, including prioritization of QA activities, oversight of QA personnel, inspection readiness, quality risk identification and escalation, and tracking of quality activities through completion. Executive Quality leadership provides strategic oversight, guidance, and escalation support for significant, complex, or organizational-level matters.

Key Responsibilities

Clinical Quality & GCP Leadership:

• Serve as ARO's functional lead for Clinical Quality Assurance and GCP compliance.
• Provide day-to-day leadership, direction, prioritization, and oversight for QA personnel and activities.
• Establish and maintain effective Clinical Quality oversight across ARO programs and applicable functional areas.
• Interpret and apply applicable ICH-GCP, NAFDAC, NHREC, and other applicable Nigerian requirements, sponsor requirements, and ARO procedures.
• Provide independent QA guidance to Clinical Operations, Regulatory Affairs, Project Management, HR/Training, Logistics, and other applicable functions while preserving functional ownership of operational activities.
• Promote a proactive culture of quality, compliance, accountability, and continuous improvement.
• Escalate significant, systemic, or emerging quality risks to executive leadership in a timely manner.
• Quality Management System Oversight
• Lead the implementation, maintenance, and continuous improvement of ARO's Quality Management System(QMS).
• Ensure controlled SOPs, policies, templates, forms, trackers, and quality tools are maintained in accordance with established requirements.
• Maintain oversight of the SOP lifecycle and ensure the SOP Index remains current, accurate, and inspection-ready.
• Ensure required periodic reviews and revisions are initiated and completed within established timelines.
• Ensure quality records are complete, accurate, traceable, appropriately controlled, and inspection-ready.
• Evaluate proposed quality processes and documentation to ensure they are necessary, risk-based, proportionate, and appropriately integrated into the existing QMS. CAPA, Deviations & Quality Issue Management
• Maintain oversight of deviations, quality issues, CAPAs, and associated effectiveness checks.
• Ensure CAPAs are appropriately documented, assigned, tracked, followed through, and closed within established timelines.
• Ensure effectiveness checks are proactively monitored and completed without requiring routine management reminders.
• Provide QA review and challenge of root cause analyses, corrections, corrective and preventive actions, and effectiveness measures.
• Trend quality issues to identify repeat or systemic risks and escalate significant concerns appropriately.
• Provide routine visibility to leadership regarding overdue, high-risk, or otherwise significant quality issues.
• Audit & Inspection Management
• Lead ARO's preparation for and support of sponsor audits, vendor audits, regulatory inspections, and other external quality assessments.
• Serve as the primary operational QA contact during applicable audits and inspections.
• Develop and maintain the organizational internal audit program in accordance with ARO procedures and risk-based priorities.
• Coordinate audit preparation, documentation, interviews, responses, CAPAs, follow-up, and closure activities.
• Ensure audit and inspection findings are tracked through appropriate resolution and closure.
• Maintain ongoing inspection readiness rather than relying solely on event-specific preparation.

Vendor Quality Oversight:

• Provide QA oversight of vendor qualification, approval, monitoring, requalification, and quality performance.
• Ensure applicable vendors are appropriately qualified before use and maintained in accordance with ARO requirements.
• Maintain oversight of vendor qualification records, approved vendor information, audit requirements, and quality documentation.
• Support review and development of Quality Agreements and quality-related contractual provisions, as applicable.
• Identify and escalate vendor quality or compliance risks.
• Partner with operational owners to ensure responsibilities between ARO and third-party providers are clearly defined and appropriately overseen; QA oversight does not replace operational ownership.

Training & Compliance:

• Provide QA oversight of the organizational training program and applicable training matrices.
• Ensure required GCP, SOP, compliance, and role-specific training is appropriately assigned, documented, tracked, and escalated when overdue.
• Identify training gaps and coordinate remediation with applicable functional leaders.
• Develop and deliver quality and compliance training when appropriate.
• Support continued development of quality awareness and ownership across ARO.

Clinical & Cross-Functional Quality Support:

• Provide risk-based QA consultation to Clinical Operations and other functional areas throughout clinical research activities.
• Support clinical study quality planning and risk management, as applicable.
• Provide QA input into regulatory inspection readiness, clinical documentation practices, vendor oversight, and study-specific compliance matters.
• Partner with functional leaders to identify appropriate corrective actions and sustainable process improvements.
• Provide quality oversight of regulatory activities without assuming operational ownership of Regulatory Affairs submissions, correspondence, or routine regulatory execution.
• Ensure QA involvement is proportionate to risk and does not unnecessarily duplicate operational responsibilities.

Quality Metrics, Risk & Management Reporting:

• Establish and maintain appropriate QA dashboards, trackers, KPIs, and quality metrics.
• Routinely monitor CAPAs, audits, training, SOPs, vendors, deviations, and other relevant quality indicators.
• Analyze trends and identify emerging or systemic risks. Provide periodic Quality updates to executive leadership summarizing performance, risks, overdue activities, significant issues, and recommended actions.
• Proactively communicate issues requiring executive attention rather than waiting for management follow-up.
• Recommend quality priorities, resource needs, and continuous improvement initiatives based on organizational risk.

QA Team Leadership:

• Provide leadership, direction, coaching, and performance oversight to assigned QA personnel.
• Establish clear responsibilities, priorities, deliverables, and timelines.
• Delegate operational QA activities appropriately while maintaining functional accountability.
• Develop QA team capabilities and support professional development.
• Ensure adequate QA coverage and continuity for organizational priorities.

Decision-Making Authority:

• The Director is expected to independently manage routine Clinical Quality and GCP matters within established ARO procedures and delegated authority.
• The Director may provide routine QA guidance, assign and prioritize QA activities, request corrective actions, coordinate audits and inspection-readiness activities, oversee CAPA and quality issue management, and escalate compliance concerns.
• Executive consultation should primarily be sought for significant regulatory or compliance risks; potential serious breaches or significant quality events; matters with substantial contractual, financial, reputational, or organizational implications; significant resource or policy decisions; unresolved cross-functional escalations; or matters requiring executive judgment.

Key Performance Indicators

• At least 95% of QA deliverables completed within agreed timelines.
• CAPAs, effectiveness checks, audits, SOP reviews, vendor qualifications, and other quality activities proactively tracked through completion.
• No overdue critical quality activities without documented justification, escalation, and mitigation.
• SOP Index and applicable QA trackers maintained current and inspection-ready.
• Internal audit program executed in accordance with the approved audit plan.
• Appropriate and timely preparation for sponsor, vendor, and regulatory audits/inspections.
• Timely escalation of significant quality and compliance risks.
• Routine QA dashboards and quality metrics provided to leadership according to the established cadence.
• Demonstrated identification and trending of recurring quality risks and implementation of appropriate improvement actions.
• Positive cross-functional stakeholder feedback regarding QA leadership, collaboration, responsiveness, and practical quality guidance.
• Demonstrated development, delegation, and effective oversight of QA personnel.

Qualifications

Education:

Bachelor's Degree in Life Sciences, Clinical Research, Pharmacy, Nursing, Public Health, Quality, or a related discipline required.

Advanced Degree and/or relevant professional quality or clinical research certification preferred.

Experience:

• Typically 7+ years of progressive experience in clinical research, GCP Quality Assurance, clinical quality, regulatory compliance, or a related area, including demonstrated GCP QA leadership responsibilities.
• Demonstrated experience leading GCP QA activities within a CRO, sponsor, biotechnology, pharmaceutical, or clinical research environment.
• Demonstrated experience with audits, inspection readiness, CAPA management, QMS activities, vendor oversight, SOP management, and quality risk management.
• Prior experience leading or supervising QA personnel strongly preferred.
• Experience supporting regulatory inspections and sponsor audits preferred.
• Experience working within Nigerian and/or broader African clinical research environments is highly desirable.

Knowledge & Competencies:

• Strong working knowledge of ICH-GCP, applicable NAFDAC clinical trial requirements and guidance,
• NHREC/Nigerian research ethics requirements, and other applicable Nigerian regulatory requirements.
• Familiarity with international sponsor expectations and regulatory frameworks applicable to multinational clinical research.
• Strong understanding of Quality Management Systems and risk-based quality management.
• Demonstrated ability to independently assess quality and compliance risks and make proportionate recommendations.
• Strong knowledge of CAPA, root cause analysis, deviation management, auditing, vendor quality oversight, document control, and training compliance.
• Strong leadership, communication, and cross-functional influencing skills.
• Ability to distinguish strategic quality risks from routine operational matters and escalate appropriately.
• Demonstrated ability to manage multiple priorities while maintaining timely follow-through.
• High level of professional judgment, integrity, independence, accountability, and confidentiality.

Role Success:

• Success in this role means that ARO maintains a stable, proactive, and inspection-ready Clinical Quality function that operates effectively without routine executive intervention.
• The Director maintains comprehensive visibility of Quality activities, ensures obligations are appropriately tracked through completion, proactively communicates risks and priorities, and independently leads routine QA operations.
• Executive Quality involvement should primarily focus on strategic direction, significant risk, organizational governance, and consultation on complex or escalated matters

Application Closing Date

30th September, 2026.

 

How to Apply

Interested and qualified candidates should send their CV and cover letter to: [email protected] using the  Job Title as the subject of the email.

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