- Company: Afro-reach Research Organisation
- Location: Wuse Zone 5, Abuja (FCT)
- Job type: Full-time
About the role
Afro-Reach Clinical Research Organization (Afro-Reach CRO) is a dedicated clinical research organization focused on delivering high-quality research and regulatory solutions. We are looking for a strategic and results-driven Director, Quality Assurance & Compliance to lead our Quality Assurance function. This role reports directly to the CEO to ensure independence and authority in quality oversight. You will be responsible for the effective implementation and continuous improvement of our Quality Management System (QMS), ensuring compliance with Good Clinical Practice (GCP) and regulatory requirements.
Responsibilities
- Provide leadership and strategic direction for the Quality Assurance function.
- Oversee the development, implementation, and maintenance of the Quality Management System (QMS).
- Conduct or coordinate independent internal audits and manage the annual Quality Audit Plan.
- Manage vendor qualification, oversight, and quality assessments.
- Oversee Corrective and Preventive Actions (CAPA), deviations, and quality risk management.
- Ensure regulatory compliance and maintain inspection readiness for sponsor audits and regulatory inspections.
- Provide independent quality oversight of clinical research activities.
- Develop and maintain quality training programs and foster a culture of quality and compliance.
- Prepare periodic Quality Management Review reports for executive leadership.
Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, Clinical Research, Healthcare, or a related scientific discipline.
- Master’s degree in Quality Management, Regulatory Affairs, or a related field is preferred.
- 8–10 years of progressive experience in Quality Assurance, preferably in clinical research, pharmaceutical, or CRO environments.
- 3–5 years of demonstrated QA leadership or management experience.
- Strong working knowledge of ICH GCP requirements and applicable clinical research regulations.
- Proven experience managing CAPAs, deviations, root cause investigations, and quality risk assessments.
- Experience preparing for or supporting sponsor audits and regulatory inspections.
- Excellent communication, analytical, and leadership skills.
How to apply
Interested and qualified candidates should send their CV to hr@afroreachcro.org using the Job Title as the subject of the email.
Apply by email: hr@afroreachcro.org
