Quality Manager - Tembisa at The Aurum Institute

Work Description: 

• The Quality  Manager is responsible for ensuring that quality standards and procedures are met and aligned with legislation and Customer specifications through managing the Organization’s quality assurance policies and controlling new product development processes. The Quality  Manager is also responsible to establish performance standards, procedures and audit controls in order to meet business requirements, identify and implement process improvements to increase efficiency, effectiveness and quality of Company operations.

YOUR JOB WILL BE TO:

• Provide leadership developing and directing quality control (QC) and quality assurance (QA) for quality department by means of attention to all processes and procedures in the delivery of projects
• Monitor QA systems and advise research  team on system performance
• Setting up and oversight of review systems necessary to ensure high quality data collection
• Setting up and oversight of regulatory systems to ensure all study documents are accurate and in accordance with ethical and regulatory procedures e.g. Investigator Site files
• Ensuring the accurate, timely, complete, ethical and efficient processing of study data in accordance with the study protocol, ethical and regulatory guidelines
• Perform gap analysis between applicable and current ICH GCP standards
• Establish and implement a quality plan to bring the company into ICH GCP compliance
• Perform internal QA audits that are compliant with the company’s policies, practices and procedures
• Implementation and evaluation of a Quality Management Program including risk analysis, verifications, validation activities and formal design reviews
• Preparation of the site for external monitoring visits
• Development, review and   implementation of protocol specific quality management plan
• Monitoring and reporting on quality issues to senior site management
• Review of pharmacy and laboratory procedures
• Review of regulatory binders
• Maintenance, version control and distribution of standard operating procedures and work practice guidelines binders
• Oversight and involvement in training of teams and individuals
• Back-up for the Programme Manager

Requirements

YOU SHOULD HAVE:

• Relevant Bachelor’s Degree or Diploma in Health Sciences
• Advantage:  Certificate in Project Management
• Advantage: GCP Certification

Work Experience:

• At least 5 years clinical research experience
• Clinical or research experience in COVID/HIV care
• Minimum of 5 years quality management experience
• Understanding of business and technology

Attributes

• Integrity
• Innovation
• Excellence
• Results Driven
• Teamwork
• Ethical
• Confidentiality
• Empathy
• Emotional Intelligence

Closing Date: 07 July 2023