Head of Quality Control

BIOVAC is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to "protect life". We are looking to hire a dynamic, passionate, confident, proactive and meticulous Head of Quality Control to join a goal-oriented team.

QUALIFICATIONS NEEDED:

• Bachelor's degree or diploma in Microbiology /Biotechnology, Pharmacy /Chemistry or equivalent.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

• At least 10 years' experience in vaccine /biotech industry or equivalent.
• At least 5 years' experience at middle to senior management level.
• Experience in quality and regulatory compliance within a cGMP facility.
• Business and operational planning.
• Program and project management
• Participation in developing a departmental budget and monitoring expenditures for multiple projects & funding sources.

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

Core Technical Delivery Functions:

• Full accountability and responsibility for all areas within Quality Control
• Full accountability for Quality Control functions including Lab Support, Compliance, Chemistry, Biological and microbiological, including stability testing and the output thereof.
• Full accountability for the analytical method transfers and operationalisation of these testing methods for the Biovac product technical transfers.
• Develop and implement QC strategies and objectives aligned with overall company goals
• Create a culture of quality and continuous improvement within the quality control teams
• Liase with senior management on quality control performance, issues, and initiatives
• Ensure compliance with cGMP and other relevant regulatory requirements and guidelines
• Align activities with business objectives, including product quality, cost management, and market competitiveness
• Collaborate with senior management to set and achieve key performance indicators (KPIs) related to quality control and overall site performance
• Drive initiatives to support business growth, process improvements, innovation, and operational efficiency
• Stay up to date with industry trends and advancements to ensure the quality control practices are current and effective
• Develop and monitor the annual budget for the quality control department in alignment with overall site goals
• Manage the planning, execution, and optimization of Laboratory Information Management Systems (LIMS) and other large-scale quality control projects.
• Oversee cross-functional project teams, ensuring timely completion of milestones and effective resolution of any issues
• Monitor QC compliance against cGMP and Biovac's Quality Management System.
• Manage internal stakeholders and customer relations through effective collaboration.
• Ensure all QC activities are documented and reviewed for accuracy timeously and pragmatically, including QC specifications, SOP's, work instructions and workflows, master batch and packaging documents.
• Ensure adequate calibration, qualifications and maintenance checks are performed against all equipment within the department.
• Monitoring and control of the production and testing environment.
• Approving and monitoring of contract laboratories, contract manufacturers and suppliers.
• Assemble and review all documentation relating to the processing, packaging, and testing of product batches before authorising release for sale.
• Develop, review, and authorise QC owned procedures, protocols and specifications for quality-controlled goods, storing of materials, sampling instructions, test methods and data sheets.
• Ensure Analytical method validation is in place for investigational and registered products.
• Oversee sampling and testing activities, data and results within the department and communicate and mitigate risks with affected stakeholders accordingly.
• Monitor and trend clean rooms, utilities and product and investigate and/ or document any OOS and OOT investigations which may require escalation & processing via the quality management system and in order to ensure correct standards are in place.
• Identify and/ or participate in inspections, investigations, risk management and quality review exercises.
• Maintain or hold a current file of approved labels, pre-printed packaging material and other specified packaging material.
• Establish expiry periods and storage instructions for incorporation in the labelling of products.
• Evaluate and authorise any re-processing or re-working of products or materials.
• Take samples for testing from any material or substance relevant to product quality to assess and handle release vs rejection rates.
• Review periodically the records relating to each product and report on compliance with standards, problems if any and recommended action.
• Carry out, co-ordinate or participate in initial and periodic process validation studies to demonstrate that materials, methods, processes and equipment are capable of doing what they purport to do, to ensure processes are effective over the range of variation selected for a particular processing parameter.
• Examine returned goods, evaluate product quality complaints, and devise plan of action to address defects.
• Lead and/ or participate in project scoping and defining of user requirements.
• Check the maintenance of the department, premises and equipment and ensure optimal operating at all time.

Application Deadline: 29 May 2026

If you do not receive a response from us within three weeks of submitting your application, please understand that your application was not successful.

We believe in the magic of diversity within teams and to achieve this, we do apply Employment Equity principles during our selection process where this is necessary to achieve such diversity.

Disclaimer:

Dear Applicant, we appreciate your interest in joining our organization. It is imperative for us that you understand how we handle your information. We are committed to ensuring the security and confidentiality of the information you provide. Your personal details will be collected for the sole purpose of the application process and will be used strictly for that purpose. By applying, you acknowledge and consent to the collection, use, and protection of your personal information in accordance with our privacy policy. If you have any inquiries or concerns, our Human Capital department is available to provide clarification. We look forward to reviewing your application.''