Quality Manager

Africa Clinical Research Network (ACRN) is an African-led clinical research organization building the next generation of trial capacity across the continent. We work with existing hospitals, research units, and investigators to enable high-quality clinical research—from investigator-initiated studies to late-phase and registration trials—while strengthening local systems, skills, and infrastructure.

ACRN operates as a pan-African site management and research delivery platform, combining strong clinical operations, regulatory expertise, data and digital systems, and quality management. Our model is practical and embedded: we focus on making trials work in real settings, reducing friction for sites, sponsors, and regulators, and delivering reliable, audit-ready data.

We partner closely with governments, regulators, academic institutions, and industry to expand Africa’s role in global clinical research, while ensuring that studies generate local value—through workforce development, institutional strengthening, and improved patient care.

At ACRN, you’ll work on meaningful, complex projects with global impact, alongside a multidisciplinary team that values rigor, accountability, and innovation. We are building something durable, ambitious, and distinctly African—and we are looking for people who want to help shape it.

About the role

The Quality Manager (IC4) is a senior individual contributor responsible for owning and overseeing ACRN’s Quality Management System (QMS) across multi-country clinical trials conducted within a regulated CRO/SMO environment. The role ensures consistent compliance with ICH-GCP, applicable regulatory requirements, sponsor expectations, and internal SOPs, while embedding a culture of quality, risk awareness, and continuous improvement across the organization.

Operating with a high degree of autonomy and authority, the Quality Manager leads audit and inspection readiness activities, oversees risk-based quality management, manages deviations and Corrective and Preventive Actions (CAPAs), and provides quality oversight of sites, vendors, and internal functions. The role serves as a quality subject matter expert (SME), produces quality metrics and dashboards, and partners closely with Clinical Operations, Regulatory Affairs, Data Management, Human Resources, and external partners to ensure inspection-ready, high-quality trial execution.

What you'll do

1. Quality Management System (QMS) Ownership

• Own, maintain, and continuously improve the organizational QMS in alignment with ICH-GCP, regulatory requirements, and sponsor expectations.
• Ensure quality processes are consistently implemented across studies, sites, and countries.
• Act as the authoritative SME for quality governance and compliance matters.

2. Audit, Inspection, and Inspection Readiness Leadership

• Lead preparation for sponsor audits, regulatory inspections, and internal quality audits.
• Conduct internal audits and quality reviews across clinical operations, sites, and vendors.
• Support and participate in external audits and inspections, including responses and follow-up actions.
• Ensure a continuous state of inspection readiness across the organization.

3. Risk-Based Quality Management (RBQM)

• Design and implement risk-based quality management approaches across clinical trials.
• Support identification, assessment, and mitigation of quality and compliance risks.
• Monitor key risk indicators (KRIs) and quality tolerance limits (QTLs) in collaboration with study teams.

4. Deviations, CAPA, and Issue Management

• Oversee identification, documentation, investigation, and resolution of deviations and non-compliances.
• Lead root cause analysis and development, implementation, and effectiveness verification of CAPAs.
• Ensure timely closure of quality issues and sustainable corrective actions.

5. Document Control and SOP Oversight

• Oversee document control processes, including SOP development, review, approval, and version control.
• Ensure SOPs, policies, and templates are current, accessible, and aligned with regulatory expectations.
• Support consistent application of controlled documents across functions and sites.

6. Site and Vendor Quality Oversight

• Provide quality oversight of investigational sites, vendors, and partners.
• Conduct site and vendor audits and assessments as required.
• Review vendor qualification, performance, and quality agreements.

7. Training Compliance and Competency Oversight

• Partner with HR and Clinical Operations to ensure training compliance across roles.
• Support development and maintenance of training matrices aligned with GCP and job responsibilities.
• Monitor training completion, effectiveness, and retraining requirements.

8. Quality Metrics, Reporting, and Management Review

• Define, monitor, and trend quality metrics and compliance indicators.
• Develop dashboards and management reports to provide visibility into quality performance.
• Present quality insights, risks, and recommendations to senior leadership.

9. Cross-Functional Partnership and Continuous Improvement

• Partner with Clinical Operations, Regulatory Affairs, Data Management, IT, and HR to embed quality into daily operations.
• Support continuous improvement initiatives, process optimization, and harmonization across studies and regions.
• Provide guidance and coaching on quality best practices without formal line management authority.

Qualifications

Minimum Qualifications

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Public Health, or a related field.

Preferred Qualifications

• Advanced degree in a scientific, clinical, or quality-related discipline.
• Formal certification in quality management, auditing, or clinical research (e.g., GCP, ISO, or equivalent).

Required Experience

• 8–12 years’ experience in clinical research quality assurance or compliance roles.
• Demonstrated experience supporting audits, inspections, and multi-country clinical trials.

Preferred Experience

• Experience working in a CRO/SMO or sponsor environment.
• Experience implementing risk-based quality management frameworks.
• Experience overseeing vendor and site quality.

Core Competencies

• Deep expertise in ICH-GCP and global clinical research regulations.
• Strong analytical and risk assessment skills.
• Ability to influence and drive compliance without direct authority.
• Exceptional attention to detail and documentation rigor.
• Clear, authoritative communication with senior stakeholders.