Accreditation Specialist

Introduction

• This role is to lead and manage the organisation’s accreditation, certification, and regulatory compliance portfolios in line with applicable standards and the requirements of HPCSA and SAPHRA.
• The role is responsible for preparing and submitting applications, including extensions of scope, managing and closing non-conformances (including NBI findings), and ensuring timely submission to relevant bodies.
• It also coordinates and maintains Site Master Files and related documentation, ensuring they are accurate, up to date, and audit-ready to support ongoing compliance and continuous improvement.

Job description

KPA 1 Financial

• Provide strategic input into the development and alignment of the 5-year Quality Systems Strategy.
• Compile annual business plan including the objectives, operational, manpower plans and CAPEX budget for the business unit.
• Communicate final business plans with all employees in the business unit and set and implement performance plans.
• Monitor, investigate and address variances to the OPEX and CAPEX budget and provide monthly report to Quality Audit and Accreditation Manager.
• Continuously monitor operational expenditure and operational trends and recommend measures to ensure continuous improvement and sustainability.
• Track performance against the approved business plan and, where deviations arise due to unforeseen factors, review and recommend appropriate adjustments to senior management.
• Oversee procurement planning and contract management processes, ensuring cost-effectiveness, compliance with organisational policies, and optimal utilisation of resources.

KPA 2 Customer and Stakeholder Relationship Building

• Monitor, evaluate and report on trends detected to the work area management and ensure quality improvement project teams address the trends detected to continually improve quality across SANBS.
• Manage and track customer complaints / queries and ensure resolution within agreed timeframes.
• Build and maintain strong collaborative relationships with key stakeholders internally and externally.
• Serve as the primary liaison between SANBS and accreditation bodies, regulatory authorities and external partners.
• Provide guidance and support to departments on accreditation, regulatory requirements and compliance expectations.
• Communicate accreditation updates, requirements, and outcomes effectively to stakeholders.
• Facilitate collaboration across departments to ensure alignment with regulations and applicable standards.

KPA 3 Internal Processes

• Ensure compliance with the Quality Management systems, accreditation and regulatory requirements, standards for practice and ISO documentation.
• Develop and maintain an administrative system for managing accreditation documentation, certificates and site licences.
• Develop and implement an administration system for the required documents that ensures traceability and tracking of changes.
• Facilitate report backs and evaluate the outcomes to ensure that projects add value to SANBS.
• Monitor performance against balance scorecard targets and implement corrective actions where targets are not met.
• Provide an input to quarterly reports for Quality Systems Management review.
• Prepare and circulate external audit reports to all relevant stakeholders.
• Coordinate and ensure review external audit meetings are held after audits, with all stakeholders.
• Review the gaps identified from external audits and compare to internal audit findings to evaluate the internal audit programme effectiveness.
• Ensure that the relevant department documentation and systems are regularly updated to ensure compliance to accreditation, regulatory bodies, applicable standards and ISO requirements.
• Identify and assess departmental operational risks for inclusion in the quality risk register.
• Analyse relevant standards and ensure alignment of SANBS policies and procedures comply with regulatory requirements.
• Prepare and review gap analysis documents annually on the requirements and SANBS documentation.
• Act as the quality representative in engagement with accreditation and regulatory bodies.
• Manage external notifications and address trends across SANBS with the management team.

KPA 4 Conduct Training and Research that leads to Innovative Implementation of Solutions

• Develop and implement a comprehensive quality training programme aligned with accreditation requirements, GMP and applicable regulations.
• Ensure effective delivery and implementation of training initiatives across SANBS to promote compliance and quality awareness.
• Develop CPD articles for SANBS for educational and professional growth.
• Perform cutting edge research in line with best practices for our leadership in the field of Quality and accreditation.
• Maintain and implement a personal development plan to ensure continuous professional growth and excellence.
• Establish a portal for innovation that will ensure execution and implementation of viable ideas from SANBS employees or stakeholders.
• Engage and participate in national and international working groups’ activities, presentations and knowledge sharing initiatives.

Minimum requirements

Education

• Medical Science qualification.
• Applicable professional registration.
• Quality qualification preferable.

Experience and knowledge requirements

• 3 years in a medical, pharmaceutical or blood transfusion industry.
• 3 years’ Quality Systems implementation experience.
• Supervisory experience.
• Driver’s licence.
• Computer literacy 

Other (knowledge and skills), e.g. understanding of relevant legislation; knowledge of relevant company procedures.

• HPCSA.
• SANC
• MS Office.
• Understanding of Blood Transfusion Standards.
• Understanding of SANAS regulations.
• GMP.
• SAHPRA / MCC.
• ISO.
• Acts and regulations.

Apply by: 26 June 2026