Senior Vaccine Quality Assurance Specialist
Must-have:QA/TestSeniorLead
About the company
A leading pharmaceutical company dedicated to empowering the fight for health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members.
Your tasks
We are seeking a passionate and talented Senior Vaccine Quality Assurance Specialist to join our dynamic team. The ideal candidate will contribute to our mission of enhancing human health and well-being, ensuring that we meet the highest standards of excellence in our industry.
- 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.
- 2 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.