Quality Assurance Associate II (South Africa)

We are seeking a highly skilled and forward-thinking Quality Assurance professional to join our team, bringing strong technical expertise within a dynamic, compliance-driven environment.

This role is ideal for someone with an advanced understanding of global regulatory frameworks such as ICH E6 (R3), 21 CFR Part 11, GAMP5, and ISO 27001, and a passion for applying risk-based validation approaches to modern, technology-enabled systems.

If you have a solid grasp of FDA GxP regulations, IT software concepts, and SaaS validation practices, enabling you to confidently navigate complex digital landscapes while maintaining the highest standards of compliance and data integrity, we’d love to hear from you.

Minimum requirements - qualifications

• Bachelor’s degree or equivalent experience and education.
• GCP and GDPR proficiency.

Minimum requirement - experience

• Minimum of 3 years Quality Assurance experience or equivalent combination of education, training, and experience in the clinical research environment including Risk-Based Quality Management, Computerized Systems Validation (CSV) and Assessments (CSA) in regulated environments (FDA GxP).
• Minimum of 3 years audit assessment and investigation experience.
• Validation lifecycle deliverables: URS, risk assessments, IQ/OQ/PQ or CSA-equivalent assurance activities.
• Conducting Supplier/Vendor audits.
• Experience with or exposure to electronic systems (e.g., EDC, eTMF, LMS, AI platforms)

Minimum requirement - skills

• Excellent interpersonal, verbal, and written communication skills.
• Excellent organizational skills.
• Superior attention to accuracy and detail. Natural aptitude for quality mindset.
• High interest or passion for technology and software.
• Strong ability to translate technical validation concepts into business language.
• Excellent problem analysis and problem-solving.
• Intermediate understanding of clinical research, the drug development process, and applicable regulatory guidelines and regulations.
• Ability to convey QA or business information with clarity and effectiveness.
• Fluent in written and spoken English.
• Team orientated and cross-cultural sensitivity.

Minimum requirements - knowledge

• Advance understanding and familiarity with ICH E6 R3, 21 CFR Part 11, GAMP5, ISO27001 requirements.
• Technical and Regulatory Expertise, in-depth understanding of risk-based validation approaches, critical thinking.
• Knowledge of tools, concepts, and methodologies of QA.
• Knowledge of relevant regulatory requirements.
• Knowledge and understanding of quality management principles.
• Knowledge of FDA GxP Regulations, IT Software terminology, SaasS validation will be an added advantage.

Key responsibilities

• Process improvement: assist with identifying non-conformances with requirements, provide suitable recommendations and facilitate ongoing quality improvements using risk-based methodology. 
  
• Supporting Supplier Qualifications or Re-Qualifications.
• Leading/supporting CSA/CSV activities for internal GxP systems.
• Supporting clients in technical aspects of usage in our validation platform.
• Supporting QA investigations, handling of Bioforum deviations and complaints.
  
• Supporting with, recommending, monitoring, and implementing CAPAs performance related to all departments together with the relevant manager.
• Problem-solving, analyze complex systems and identify control gaps.
• Identify training needs in conjugation with professional stakeholders and organize training interventions to meet quality standards and for the development of Bioforum skills.
  
• Support the internal and external audits, evaluate audit findings, and implement appropriate corrective actions.
  
• Monitor risk management activities and initiate / attend quality related or risk-based monitoring meetings.
  
• Work in collaboration with other stakeholders that interlink with QA department to ensure quality expectations are aligned.
  
• Action any quality initiatives as identified and approved by Bioforum management.
  
• Review and/or co-author controlled documents.
• Assess Supplier QMS maturity, computer system controls, review data integrity practices.
• Engage with AI models to perform work and/or determine initiative pre-approvals.
• May act as Subject Matter Expert (SME) for Validify services.
• May participate in or provide support with Validify services.