Director, Quality Assurance & Compliance at Afro-Reach Clinical Research Organization – Abuja

Afro-Reach Clinical Research Organization is recruiting a Director of Quality Assurance and Compliance in Wuse Zone 5, Abuja. Reporting to the CEO, the Director will lead the independent quality assurance function and oversee the organisation’s quality management system, audit programme and regulatory compliance.

Responsibilities

• Lead QA governance, departmental planning, staffing and quality decision-making while independently advising executive leadership on material risks.
• Establish, maintain and continuously improve a risk-based Quality Management System, including SOPs, document control, training records, change control and quality record retention.
• Plan and supervise internal and vendor audits, annual audit programmes, qualification assessments, audit responses, corrective actions and verification of their effectiveness.
• Oversee deviation, nonconformance and CAPA processes, including investigations, root-cause analysis, trend monitoring, escalation and risk mitigation.
• Maintain inspection readiness and provide QA leadership during sponsor audits, qualification assessments and regulatory inspections, including compliance with ICH GCP E6(R3) and applicable local regulations.
• Provide independent, risk-based quality oversight of clinical research, study-level quality planning, vendor quality agreements and delegated compliance responsibilities.
• Coach QA personnel and coordinate quality training, awareness, matrices and training compliance monitoring.
• Prepare management reviews and metrics covering audits, CAPAs, training, vendors, deviations and inspection readiness; recommend priorities and resources.
• Work collaboratively with Clinical Operations, Regulatory Affairs, Project Management and other departments without assuming responsibility for their routine operational decisions.

Qualifications and experience

• Bachelor’s degree in Life Sciences, Pharmacy, Clinical Research, Healthcare or a related scientific discipline.
• A master’s degree in Quality Management, Regulatory Affairs, Clinical Research, Public Health or a related field is preferred. QA, GCP audit or quality-management certification is desirable.
• Eight to ten years of progressive quality assurance experience, preferably in clinical research, pharmaceutical, biotechnology or CRO operations.
• Three to five years of QA leadership or management experience, including accountability for programmes, staff and compliance.
• Practical experience managing quality systems, GCP and vendor audits, CAPAs, investigations, inspection preparation and quality-risk assessment.
• Sound understanding of ICH GCP and clinical research requirements, and the ability to provide independent advice to senior leadership.
• Strong audit, reporting, analytical, technical leadership, communication, confidentiality, prioritisation and cross-functional skills.
• Proficiency in Microsoft Office, SharePoint and electronic quality or document management systems.

Work arrangement and authority

• Regular on-site attendance is expected at the Abuja office; remote work may be approved according to operational needs.
• Occasional travel to research sites or vendors and coordination across international time zones may be required.
• The Director supervises QA personnel and makes routine decisions within delegated authority, reporting significant quality, regulatory, financial or structural matters to executive leadership.
• The role reports to the CEO and liaises with the Executive Consultant for strategic quality guidance while retaining responsibility for day-to-day QA operations.