Head of Department: Quality and Regulatory at The Aurum Institute

Description

The HOD Quality and Regulatory is responsible for ensuring that quality standards and procedures are met and aligned with legislation, protocol requirements, and customer specifications through managing the CRD policies and SOPs. The Role will establish performance standards, procedures, and audit controls to meet research requirements and identify and implement process improvements to increase efficiency, effectiveness, and quality of study implementation.

Responsibilities

• Provide leadership developing and directing QA and quality improvement initiatives for all research activities.
• Responsible for establishing performance standards, procedures, and audit controls to meet research requirements, and identify and implement process improvements to increase efficiency, effectiveness, and quality of research operations.
• Establish, implement, and evaluate a Clinical Quality Management Plan (CQMP) to bring the division into GCP compliance including risk analysis, verifications, and formal reviews.
• Setting up and oversight of review systems necessary to ensure high-quality data collection.
• Monitor QA systems and advise the team on system performance.
• Review study data accurately, timely, completely, ethically, and efficiently in accordance with the study protocol, ethical and regulatory guidelines
• Review the recording, reviewing, and data capturing of selected studies.
• Perform internal audits that are compliant with the company’s policies, practices, and procedures.
• Perform gap analysis between applicable and current GCP standards.
• Prepare quality documentation and Reports by collecting, analysing, and summarising information and trends.
• Monitoring and reporting on quality issues to senior management
• Writing and updating quality procedures
• Maintenance, version control, and distribution of electronic procedural documents (Policies, SOPs/WPGs).
• Manage all documented evidence.
• Quality Management System set-up, gaps analysis, and CAPA development.
• Review quality (CAPA) documentation before it is sent out to external stakeholders.
• Involved in data privacy as required to ensure POPIA compliance.
• Lead for internal and external audits, hosting inspections, and maintenance of the QMS.
• Perform mock regulatory inspections and assist sites and Sponsors with regulatory inspection preparation and follow-up.
• Oversee and coordinate all regulatory aspects of trials including Regulatory Authority and Ethics Committee/IRB submissions.
• Setting up and oversight of regulatory systems to ensure all study documents are accurate and in accordance with ethical and regulatory procedures.
• Review of regulatory binders

Requirements

Education

• Relevant Bachelor’s degree from four-year college or university

Advantageous

• Masters Degree
• Certificate in Project and Quality Management
• GCP Certification
• Knowledge of SA and ICH GCP and GCLP guidelines and an excellent working knowledge of international clinical trial-related regulations, policies, and guidelines (EMA, FDA, MHRA, SAHPRA, and several African Regulatory agencies).

Experience

• Clinical research experience in TB/HIV care
• At least 5 years clinical research experience
• Minimum of 5 years quality and regulatory management
• Understanding of business and technology operations
• Management of quality assurance
• Experience in risk management
• Quality assurance system applications
• Report writing
• Liaise with internal and external stakeholders
• Attention to detail
• Problem-solving
• Judgement and decision making

Requirements

• Driver’s licence
• Proficient MS Word computer skills
• SA Citizen or valid work permit to work in South Africa
• Own car
• Moderate overnight travel (up to 30%) by land or air if required.