Overall Purpose of the Position:
The Internal Auditor is responsible for independent planning, executing and reporting on audit activities across TASK Clinical teams and TASK operational teams. The role ensures consistent compliance with SA GCP and ICH-GCP E6 latest versions), international guidelines (FDA and EMA), as well as local regulatory and ethical requirements and TASK standard operating procedures (SOPs) and policies. The Internal Auditor acts as a quality sentinel – policing, coaching and strengthening clinical quality systems to uphold the highest scientific, ethical and regulatory standards.
Key Performance Areas (KPAs) & Responsibilities include, but not limited to:
Audit Planning & Execution
- Developing implementing and maintaining an annual audit plan in line with company objectives and risk assessments
- Conducting comprehensive internal audits across clinical operations as well as any TASK electronic systems and processes, safety reporting and other functional areas
- Executing audits independently, with a focus on evidence-based findings, root cause analysis, and compliance against ICH-GCP E6 (R3), SA GCP 2020 (or the latest versions), and applicable international and local regulatory requirements
Reporting & Follow-Up
- Preparing clear, concise and objective audit reports summarising recommendations, findings, impacts, and risks and applying applicable grading system (i.e. minor, major or critical) with justifications and corrective/preventive action recommendations
- Accepting and following up on CAPA (Corrective and Preventive Action) plans to ensure effective and timeous resolution and closure
- Presenting audit outcomes and insights to senior leadership and functional teams
- Evaluating audit specific CAPA effectiveness after a period (e.g. 6 months) to report on continued success of implementation and adherence or relapse of CAPAs
Governance & Quality Improvement
- Promoting a culture of quality by providing independent oversight, objective feedback, and formal audit-based recommendations to clinical and operational teams
- Monitoring trending issues and emerging risks, driving continuous improvement within the quality management framework
- Partnering with quality assurance and training teams to elevate awareness and adherence to GCP standards, regulatory requirements and SOPs
- Staying abreast of the latest regulatory guidelines, international standards, and ethical requirements in clinical research, ensuring TASK policies, procedures, and operations remain aligned with evolving compliance expectations
Training & Consultancy
- Advising and educating cross-functional colleagues on audit outcomes, best practices and regulatory expectations
- Contributing to training and coaching on GCP compliance topics
Ideal Requirements
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Biomedical Science, or related
- Advanced certification in Clinical Research, Quality Assurance or Auditing (e.g., Certified Clinical Research Professional (CCRP/ACRP), Certified Quality Auditor (CQA) or equivalent)
- ICH-GCP certification (training and practical knowledge of ICH-GCP E6 (R3) compliance requirements)
- 5+ years clinical research quality, auditing or compliance experience in clinical operations within a CRO, site or sponsor environment
- Demonstrated experience conducting independent internal audits with measurable impact
- Solid understanding of clinical trial conduct (Phase I–IV), regulatory submissions and TMF/ISF management
- Exposure to multi-site audits, data integrity and system checks, and regulatory inspections is a strong advantage
- SA GCP 2020
- NDoH 2024 certification
- Familiar with FDA and EMA regulatory requirements
- Expert knowledge of SA GCP 2020 and ICH-GCP E6 R3 (or latest versions), local and international regulations and industry standards governing clinical trials
- Proficient in audit methodologies, CAPA tracking systems and audit reporting tools
- Ability to interpret and apply complex regulatory and procedural requirements
- Drivers licence and own transport (beneficial)
Key Personal Inherent Characteristics
- High Integrity & Accountability: Upholds ethical standards, reliable in owning outcomes.
- Fearless Quality Champion: Comfortable challenging the status quo and escalating issues where necessary.
- Influential Communicator: Articulates complex audit findings effectively, at all organisational levels.
- Solution-Driven & Resilient: Turns compliance challenges into opportunities for better practice.
- Respectful Enforcer: Balances assertiveness with respect; holds teams accountable while building trust.
- Continuous Learner: Keen on staying abreast of evolving regulatory and industry trends
Details:
Area:Parow, Cape Town
Contract Type:Permanent
Applications Close: 20 March 2026 (15:00)
Please indicate in your application that you are applying for the above-mentioned position and include a cover letter, applications without a cover letter will not be considered.
If you have not received a response within one month, your application was most likely unsuccessful.
TASK reserves the right to withdraw this advertisement and not fill the above-mentioned vacancy at any stage during the recruitment process.
We believe great talent comes in many forms and encourage suitably qualified candidates with disabilities to apply. Meeting our employment equity goals will be acknowledged during the recruitment process.
By responding to this advert and sending your cv, cover letter and/or any other documentation, you are consenting to TASK processing your personal information as contained in the furnished documents. TASK may process your personal information for recruitment purposes for suitable posts that may arise within the organisation. You agree that you have familiarised yourself with South Africa’s Protection of Personal Information Act and understand your rights and obligations under this Act.
