Director, Quality Assurance & Compliance

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 analysis and development of effective corrective and preventive actions.

Monitor CAPA implementation timelines, closure documentation, and effectiveness checks.

Review quality trends and recurring issues to identify systemic risks.

Establish risk-based escalation processes for significant quality or compliance concerns.

Ensure appropriate documentation and communication of quality decisions.

Support proactive quality risk identification, assessment, mitigation, and monitoring.

Regulatory Compliance and Inspection Readiness:

Provide independent oversight of compliance with applicable GCP requirements, including ICH E6(R3), and relevant local regulatory requirements.

Monitor changes in applicable regulations, guidelines, and industry expectations and assess their impact on ARO's operations.

Establish and maintain an organizational inspection readiness program.

Coordinate QA preparation and support for sponsor audits, regulatory inspections, and qualification assessments.

Oversee the preparation, review, and tracking of audit and inspection responses.

Ensure appropriate follow-up and implementation of commitments arising from inspections and external audits.

Support functional teams in maintaining appropriate documentation and evidence of compliance.

Serve as the primary QA representative during sponsor audits, vendor assessments, and regulatory inspections, as applicable.

Clinical Quality Assurance Oversight:

Provide independent, risk-based QA oversight of clinical research activities performed by ARO.

Collaborate with Clinical Operations, Regulatory Affairs, Project Management, and other functional teams to identify and manage study-related quality risks.

Review applicable study-level quality plans, quality agreements, and oversight arrangements.

Support risk-based quality planning for new studies, services, and operational activities.

Assess significant protocol deviations, GCP compliance concerns, and quality events within ARO's delegated responsibilities.

Ensure appropriate escalation of significant quality concerns to ARO leadership, sponsors, and other stakeholders in accordance with applicable requirements.

Provide quality input into clinical research processes, monitoring oversight frameworks, and inspection readiness activities.

Maintain independent QA oversight without assuming responsibility for routine clinical operations or study execution.

Training and Quality Culture:

Establish and maintain a structured quality training and awareness program.

Oversee the development and maintenance of applicable training matrices and training compliance monitoring.

Coordinate quality-related training initiatives and regulatory updates.

Support functional managers in ensuring personnel understand their responsibilities under applicable procedures.

Promote proactive identification and reporting of quality concerns.

Provide coaching and technical guidance to QA personnel and other employees on quality-related matters.

Foster an organizational culture that prioritizes patient safety, data integrity, compliance, and continuous improvement.

Quality Reporting and Management Review:

Develop and maintain quality performance metrics and reporting mechanisms.

Provide periodic Quality Management Review reports to executive leadership.

Monitor key indicators, including audit findings, CAPA status, training compliance, deviations, vendor qualification, and inspection readiness.

Identify trends, emerging risks, and opportunities for improvement.

Recommend quality priorities, resource needs, and improvement initiatives.

Ensure significant quality concerns are communicated promptly to appropriate leadership.

Maintain clear documentation of management review outcomes, decisions, and follow-up actions.

Organizational Structure and Functional Boundaries

The Director, Quality Assurance & Compliance will serve as the operational head of ARO's Quality Assurance function.

The role will have direct responsibility for managing QA activities, supervising QA personnel, and making routine quality-related decisions within established authority:

Executive Leadership:

The Director will report directly to the CEO to support the independence of the QA function.

The Director will provide regular updates on quality performance, compliance risks, audit findings, and improvement initiatives.

The Director will have direct access to the CEO for escalation of significant quality concerns.

Executive leadership will retain responsibility for organizational strategy, resource allocation, and business decisions.

Executive Consultant – Organizational Strategy & Quality Assurance:

The Executive Consultant will provide strategic quality guidance, independent advisory support, and periodic oversight of the organization's quality framework.

The Director will assume primary responsibility for the day-to-day management and execution of QA activities.

The Director may consult the Executive Consultant on significant quality risks, complex compliance matters, organizational quality strategy, or major inspection-related concerns.

The Executive Consultant may periodically review quality performance, provide recommendations, and support leadership in evaluating the effectiveness of the QA function.

Routine QA reviews, approvals, audit coordination, CAPA follow-up, and operational quality decisions will remain the responsibility of the Director.

The Executive Consultant will not serve as the default approver or operational decision-maker for routine QA activities.

Quality Assurance Personnel:

QA personnel will report through the established QA organizational structure to the Director.

The Director will assign responsibilities, supervise performance, provide technical guidance, and ensure appropriate quality resources are available.

The Director will be accountable for the quality and timeliness of departmental deliverables.

Existing QA personnel will continue to perform their assigned responsibilities under the Director's leadership.

Clinical Operations, Regulatory Affairs, and Other Functional Departments:

Functional leaders will retain responsibility for executing activities within their respective departments.

The Director will provide independent quality oversight, compliance guidance, and risk-based assessments.

The Director will not assume operational ownership of clinical monitoring, regulatory submissions, logistics execution, or project management activities.

Functional owners will remain accountable for implementing corrective actions arising from their processes.

The Director will have authority to escalate unresolved compliance risks and recommend appropriate restrictions or corrective measures in accordance with approved procedures.

Key Performance Indicators (KPIs)

QMS Effectiveness:

Timely review and maintenance of controlled quality documents.

Implementation of identified QMS improvements.

Effectiveness of quality processes and controls.

Audit and Inspection Readiness:

Completion of planned internal and vendor audits.

Timely issuance and closure of audit reports.

Readiness for sponsor audits and regulatory inspections.

Timely implementation of audit and inspection commitments.

CAPA and Quality Event Management:

Timely investigation and closure of quality events and CAPAs.

Effectiveness of implemented corrective and preventive actions.

Reduction in recurring or systemic quality findings.

Training and Compliance:

Completion of required quality training.

Timely implementation of applicable regulatory and procedural updates.

Improved employee awareness of quality responsibilities.

Vendor Quality Oversight:

Timely completion of applicable vendor qualification and reassessment activities.

Appropriate management of vendor quality risks and findings.

Maintenance of required quality agreements.

Leadership and Departmental Performance:

Timely completion of QA departmental deliverables.

Effective supervision and development of QA personnel.

Appropriate identification, documentation, and escalation of significant compliance risks.

Ability to independently manage the QA function with minimal reliance on executive consultants for routine operational activities.

Specific performance targets will be established during onboarding and reviewed periodically.

Qualifications and Experience

Education:

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.

Relevant professional certifications in Quality Assurance, GCP auditing, or quality management are desirable.

Mandatory Professional Experience:

8–10 years of progressive experience in Quality Assurance, preferably within clinical research, pharmaceutical, biotechnology, or CRO environments.

At least 3–5 years of demonstrated QA leadership or management experience, including responsibility for quality programs, personnel, and compliance oversight.

Demonstrated experience developing, implementing, or managing a Quality Management System.

Proven experience conducting and managing GCP audits, vendor qualification audits, and internal compliance assessments.

Experience managing CAPAs, deviations, root cause investigations, and quality risk assessments.

Demonstrated experience preparing for or supporting sponsor audits and regulatory inspections.

Strong working knowledge of ICH GCP requirements and applicable clinical research regulations.

Experience providing independent quality oversight and advising senior leadership on compliance risks.

Demonstrated ability to independently manage quality-related decisions, priorities, and escalations.

Preferred Experience:

Previous experience as a QA Director, Senior QA Manager, Head of Quality, or equivalent position.

Experience within a CRO or sponsor organization supporting multinational clinical trials.

Familiarity with clinical research regulatory requirements in Nigeria and other sub-Saharan African countries.

Experience supporting sponsor qualification audits, regulatory inspections, and vendor oversight programs.

Experience developing or strengthening quality systems within a growing organization.

Experience managing outsourced services and quality agreements.

Required Skills and Competencies:

Strong technical knowledge of GCP, QMS principles, and quality risk management.

Proven leadership and personnel management capabilities.

Excellent audit planning, execution, reporting, and follow-up skills.

Strong analytical thinking, root cause analysis, and problem-solving abilities.

Ability to independently assess compliance risks and make objective, defensible decisions.

Excellent written and verbal communication skills.

Ability to communicate quality concerns effectively to executive leadership and external stakeholders.

Strong organizational and project prioritization skills.

High level of integrity, independence, confidentiality, and professional judgment.

Ability to manage competing priorities and work with minimal supervision.

Strong interpersonal and cross-functional collaboration skills.

Proficiency in Microsoft Office, SharePoint, and electronic quality or document management systems.

Decision-Making Authority:

The Director, Quality Assurance & Compliance will have delegated authority to manage the Quality Assurance function and make routine quality-related decisions in accordance with approved organizational procedures.

Authorized Responsibilities:

Establish and manage QA priorities, work plans, and departmental activities.

Assign and supervise QA personnel.

Approve quality documents and records within the designated approval framework.

Develop and implement the annual audit program.

Approve audit reports, CAPA assessments, and quality-related documentation within delegated authority.

Conduct and coordinate vendor qualification and quality assessments.

Recommend vendor qualification status based on documented risk assessments.

Identify, document, and escalate compliance risks.

Require appropriate investigation and corrective action for identified quality concerns.

Recommend suspension or restriction of activities presenting significant compliance risks, subject to applicable escalation and decision-making procedures.

Represent the QA function in sponsor, vendor, and regulatory interactions.

Matters Requiring Executive Consultation or Approval:

Significant organizational quality risks with potential patient safety, regulatory, or business implications.

Major changes to the organization's quality strategy or QMS governance framework.

Significant financial commitments or additional resource requirements.

Organizational restructuring or changes to QA reporting relationships.

Decisions requiring CEO authorization under established organizational policies.

Significant regulatory inspection outcomes or critical compliance concerns.

The Director must have the authority to independently report quality concerns without inappropriate operational or commercial influence.

Work Schedule and Expectations:

This is a full-time leadership position requiring active engagement with ARO's operational teams and management:

The position is expected to maintain a regular on-site presence at ARO's designated office.

Remote work arrangements may be approved in accordance with organizational requirements.

The Director must remain accessible during established working hours and be available to support urgent quality or compliance matters.

Occasional travel to clinical research sites, vendors, or other operational locations may be required.

The position may require participation in meetings with international sponsors, CROs, and business partners across different time zones.

Leadership Expectations:

ARO is seeking an experienced quality leader who can independently manage the QA function while strengthening the organization's quality culture and compliance framework.

The successful candidate must demonstrate the ability to:

Take ownership of the QA function and its day-to-day activities.

Exercise independent, objective, and risk-based judgment.

Lead and develop QA personnel effectively.

Establish clear departmental priorities and accountability.

Identify compliance risks proactively and implement sustainable improvements.

Communicate quality concerns constructively and confidently.

Maintain appropriate independence from operational functions.

Collaborate effectively with executive leadership and functional departments.

Support organizational growth without compromising quality or compliance.

Recognize when strategic consultation or executive escalation is appropriate.

The primary objective of this position is to establish a sustainable, independently managed Quality Assurance function that ensures regulatory compliance, strengthens organizational quality systems, supports inspection readiness, and enables ARO's executive leadership and consultants to focus on strategic oversight and organizational development.

Minimum qualifications

BA/BSc/HND

How to apply

Interested and qualified candidates should send their CV to: hr@afroreachcro.org using the ob Title as the subject of the email.

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