Vaccine Quality Assurance Section Head

Job Summary:

We are seeking a passionate and talented Vaccine Quality Assurance Section Head to join our dynamic team.

Key Responsibilities:

• Lead QA activities within Sterile Production Operations, ensuring full compliance with sterile manufacturing best practices and regulatory requirements.
• Manage and maintain a robust Quality Management System, integrating ISO standards related to Quality, Environment, and Health & Safety.
• Own and oversee key QA processes, including Change Control, Deviations, Product Recalls and Mock Recalls, Annual Product Quality Reviews, and Customer Complaint management.
• Drive continuous improvement through digitalization initiatives and the application of modern QA tools and statistical approaches such as Minitab.
• Act as the main QA point of contact with Regulatory Affairs, Export, Supply Chain, R&D, and Laboratory teams to ensure effective cross-functional collaboration.
• Support performance management by aligning departmental activities with company KPIs and annual objectives, with preference given to experience in biotechnology and vaccine manufacturing.

Requirements

• Bachelor's degree in Pharmacy.
• 8 years+ of proven experience in sterile manufacturing environments.
• Strong knowledge of ISO standards and pharmaceutical GMP requirements, including EU, WHO, and EDA regulations.
• Demonstrated ability to lead teams, manage complex negotiations, and apply constructive problem-solving to operational bottlenecks.
• Excellent interpersonal and communication skills with the ability to engage effectively across diverse technical and commercial stakeholders.
• A proactive and innovative mindset, with a proven track record in system optimization.