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.

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

• 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.

• 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…