Head of Production at Biovac

• 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 Production to join a goal-oriented team.

QUALIFICATIONS NEEDED:

• Relevant scientific or Business Management tertiary qualification
• Bachelor's degree in a relevant Health Sciences, Engineering field or equivalent.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

• 10 to 15 years of progressively responsible experience in pharmaceutical GMP production environments with a minimum of 5 years' experience within commercial sterile operations.
• Minimum of 10 years' experience in a leadership or management role, overseeing production operations and cross-functional teams.
• In-depth knowledge of regulatory requirements and quality standards pertaining to vaccine manufacturing, including GMP guidelines and relevant industry regulations.
• Proven track record in driving process improvement initiatives, optimizing manufacturing processes, and implementing new technologies to enhance production efficiency and product quality.
• Experience in commercial aseptic fill/finish operations.
• Experience in transitioning from start-up to commercial manufacturing.
• Experience in having faced successful local and/ or international quality audits.
• Experience in drug substance manufacturing and biosafety level processing.

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

• Core Technical Delivery:
• Compliance with GMP and Regulatory Standards: Ensuring that all activities within the facility are carried out in strict adherence to Good Manufacturing Practices and other relevant regulatory requirements. This includes maintaining records, implementing standard operating procedures (SOPs), and conducting regular audits to ensure compliance.
• Operational Strategy and Planning: Developing and implementing the operational strategy for the facility. This involves setting goals, defining performance metrics, and creating action plans to meet production targets while maintaining quality and safety standards.
• Production Management: Overseeing the drug substance, aseptic fill/finish manufacturing process, ensuring that it is efficient, reliable, and meets production schedules. This involves coordinating with various departments, such as manufacturing, quality assurance, and supply chain, to optimize production workflows.
• Quality Assurance and Control: Collaborating with the Quality Assurance department to establish and maintain a robust quality management system. This includes conducting investigations into deviations, implementing corrective and preventive actions (CAPAs), and continuously improving the quality processes.
• Resource Management: Managing human and material resources efficiently to meet operational demands. This includes workforce planning, training, and development, and ensuring an adequate supply of raw materials and components.
• Health, Safety, and Environmental Compliance: Ensuring a safe working environment for all employees and compliance with environmental regulations. This involves implementing safety protocols, conducting safety training, and addressing any environmental concerns.
• Continuous Improvement Initiatives: Identifying areas for improvement in processes and operations and implementing initiatives to increase efficiency, reduce waste, and optimize productivity.
• Budget and Cost Management: Developing and managing budgets for the operational departments. This includes cost control measures and finding opportunities for cost savings without compromising quality and compliance.
• Collaboration and Communication: Facilitating effective communication and collaboration between different departments within the facility. This includes regular meetings, cross-functional team coordination, and reporting to higher management.
• Regulatory Inspections and Audits: Preparing for and participating in regulatory inspections and audits by external agencies. Ensuring all necessary documentation and processes are in place to demonstrate compliance during these inspections.
• Risk Management: Identifying and mitigating operational risks that could impact production or quality. Developing contingency plans to handle unexpected events or issues.
• Long-Term Planning and Expansion: Contributing to the long-term growth and expansion plans of the facility by evaluating capacity requirements, identifying opportunities for process improvements, and participating in strategic decision-making.
• Application Deadline: 12 September 2025