Director, Quality Assurance & Compliance

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, Quality Assurance & Compliance

Location: Wuse Zone 5, Abuja (FCT)

Employment Type: Full-time

Work Arrangement: Primarily On-site; Remote Work as Approved

Reports To: Chief Executive Officer (CEO) Supervisory Responsibility: Quality Assurance personnel and designated quality-related resources Functional Relationship: Executive Consultant – Organizational Strategy & Quality Assurance Position Summary Afro-REACH Research Organization (ARO) is seeking an experienced, strategic, and results-driven Director, Quality Assurance & Compliance to lead the organization's Quality Assurance function and ensure the effective implementation, maintenance, and continuous improvement of its Quality Management System (QMS). The Director will serve as ARO's primary operational authority for quality assurance, regulatory compliance oversight, audit management, inspection readiness, and quality risk management across the organization's clinical research and supporting business activities. The successful candidate will be responsible for establishing a proactive, risk-based approach to quality management, ensuring compliance with applicable Good Clinical Practice (GCP), regulatory requirements, contractual quality obligations, and organizational policies and procedures. This position requires a highly experienced quality professional capable of independently managing the QA function, providing objective compliance oversight, advising leadership on quality risks, and supporting the organization's continued growth. The Director will work collaboratively with executive leadership, functional department heads, and external stakeholders while maintaining the independence and authority necessary for effective quality oversight.

Key Responsibilities

Quality Leadership and Governance: Provide overall leadership, strategic direction, and operational management of ARO's Quality Assurance function. Serve as the primary point of contact for quality-related matters across the organization. Develop and implement quality strategies, objectives, and improvement initiatives aligned with organizational priorities. Establish and maintain an effective, risk-based Quality Management System appropriate to ARO's operations and services. Ensure clear quality responsibilities, reporting structures, and escalation mechanisms. Provide independent quality oversight of clinical research activities and supporting operational functions. Advise executive leadership on quality performance, compliance risks, emerging issues, and recommended actions. Promote a culture of quality, accountability, continuous improvement, and regulatory compliance. Quality Management System Oversight: Oversee the development, implementation, maintenance, and periodic review of ARO's QMS. Ensure appropriate governance of Standard Operating Procedures (SOPs), work instructions, templates, forms, and quality-related records. Manage the document control process, including review, approval, version control, distribution, and periodic review. Oversee the training management process to ensure personnel receive appropriate training on applicable procedures and regulatory requirements. Ensure quality records are appropriately maintained, accessible, and retained in accordance with applicable requirements. Oversee quality change control processes and assess the impact of changes to procedures, systems, and operational practices. Identify QMS gaps and implement sustainable improvements. Evaluate the need for additional quality systems, tools, and resources as organizational operations expand. Internal Audits and Quality Oversight: Develop, implement, and maintain a risk-based internal audit program covering applicable ARO functions and activities. Prepare and manage the annual Quality Audit Plan. Conduct or coordinate independent audits of internal departments, processes, systems, and applicable clinical research activities. Ensure audit findings are appropriately classified, documented, communicated, and tracked through resolution. Oversee audit responses, corrective actions, and effectiveness verification. Identify recurring audit observations and systemic compliance risks. Ensure audit activities maintain appropriate independence from the functions being assessed. Provide regular audit status updates and quality risk summaries to executive leadership. Vendor Qualification and Oversight: Establish and oversee risk-based quality qualification and reassessment processes for applicable vendors, subcontractors, and service providers. Conduct or coordinate vendor qualification audits and quality assessments. Review vendor quality documentation, compliance history, and risk profiles. Support the development, review, and maintenance of Technical Quality Agreements and other quality-related contractual arrangements. Monitor vendor quality performance, significant deviations, audit findings, and corrective actions. Collaborate with functional owners to ensure appropriate vendor oversight and accountability. Escalate significant vendor compliance concerns and recommend appropriate risk mitigation measures. CAPA, Deviations, and Quality Risk Management: Oversee the identification, documentation, investigation, and management of quality events, deviations, nonconformances, and CAPAs. Ensure appropriate root cause analy