Quality Assurance Associate II – Regulatory & SaaS Validation

About the role

We are looking for a highly skilled Quality Assurance Associate II to join our compliance‑driven team in South Africa. The role focuses on risk‑based validation of modern, technology‑enabled systems within a regulated clinical research environment.

Key responsibilities

• Identify non‑conformances, recommend corrective actions and drive continuous quality improvement using risk‑based methodologies.
• Support supplier qualification and re‑qualification activities, including vendor audits.
• Lead and support Computerized Systems Validation (CSV) and Computer System Assessment (CSA) activities for internal GxP systems.
• Assist clients with technical aspects of system usage, ensuring compliance with regulatory standards.
• Prepare validation lifecycle deliverables such as URS, risk assessments, IQ/OQ/PQ documentation.

Required profile

• Bachelor’s degree or equivalent experience.
• Minimum 3 years of Quality Assurance experience in a clinical research or regulated environment.
• Proficiency in GCP and GDPR.
• Strong audit, assessment and investigation experience.
• Excellent written and verbal communication in English, with strong organizational and detail‑orientation skills.

Required skills

• ICH E6 R3, 21 CFR Part 11, GAMP5, ISO 27001.
• FDA GxP regulations, CSV, CSA.
• Risk assessment, IQ/OQ/PQ execution.
• Supplier/vendor audit experience.
• Familiarity with electronic systems such as EDC, eTMF, LMS, AI platforms.
• GCP and GDPR knowledge.