Job Description
Bavarian Nordic - Protecting our tommorow
At Bavarian Nordic, we are committed to saving and improving lives by unlocking the power of the immune system. Our commercial product portfolio includes market-leading vaccines against smallpox, mpox, rabies, tick-borne encephalitis, typhoid fever, chikungunya and cholera. We excel in R&D innovation, manufacturing, and commercialization, striving to improve the health and quality of life for people worldwide, ultimately protecting our tomorrow. Join us in our mission to make a difference.
Become the trusted Quality Assurance Expert to our R&D QA team in the QA department!
In the R&D QA team, we are devoted to managing a robust quality management system to assure data integrity and subject safety throughout the product development from Phase I-III clinical trials all the way though to post marketing, to secure regulatory requirements and expectations.
Our team is embedded into a larger quality organization, dedicated to accompanying Bavarian Nordic through an exciting phase of new products, markets and business areas. You will be reporting to directly to the head of R&D QA and be part of a team of a Global Quality Assurance Staff located in Germany, Denmark, Canada and in the US that are supporting GCP, GLP, GCLP and Pharmacovigilance, providing opportunities for cross-functional collaborations and interesting development opportunities.
Bavarian Nordic is growing in many aspects and offers an opportunity for advancement and learning and provides flexible work-from-home possibilities made in agreement with your manager.
You will be part of a global and fully integrated vaccine company committed to improving and saving lives through innovative vaccines.
This is how you impact the people we are here to serve
Our vaccines make a real difference to people, and no matter your role we all contribute to protecting lives every day. This is how your work matters:
- Collaborate with stakeholders in the development department to support clinical trial programs for Bavarian Nordic compounds in our pipeline and for marketed products
- Establish appropriate activities supporting the management and oversight of quality for clinical trial programs and processes, Investigational sites and vendors
- Support inspection readiness activities
- Prepare and host inspections from regulatory authorities
- Maintain and track change control, investigations, deviations and CAPAs to closure
- Support the development and maintenance of the corporate GCP audit programs
- Perform internal and external audits as a lead auditor or as a co-auditor
- Support with oversight over subcontracted contracted audit programs
- Support development, maintenance and continuous improvement of the Quality Management System (QMS)
- Participate in development projects and provide support in the context of clinical risk management
- University degree (B.Sc or above) in natural sciences or a comparable qualification
- Demonstrated knowledge of ICH GCP, global regulations and guidelines applicable for the conduct of clinical trials – demonstrated knowledge of pharmacovigilance strongly preferred
- Minimum 7 years of experience in QA or in quality-oriented work supporting clinical trials
- Experience of developing audit and/or quality oversight strategies in GxP areas
- Experience of preparing for and hosting regulatory inspections
- Knowledge of applied risk management and the review of continuous risk management
- Demonstrated strong analytical, problem-solving, and decision-making skills
- Demonstrated experience in managing projects
- Fluency in written and spoken English
A chance to work in an international company with unique technology and a dedicated workforce. We offer being part of a dedicated and agile global regulatory affairs team. We welcome people who share our passion for regulatory affairs with a willingness to make a difference. We offer a dynamic and flexible work environment and an opportunity to develop both your personal and academic competencies.
Does this sound like the right job for you?
View More