QA Specialist - GCLP

Are you passionate about Quality Assurance in clinical and pre-clinical research? Do you thrive in an international environment, ensuring compliance with global regulatory standards? Then this opportunity might be for you!

Your Responsibilities

1. Ensure compliance with FDA, EMA, OECD, and other regulatory requirements for GCLP, GCP, and GLP studies.
2. Conduct internal and external audits, including audit planning, execution, reporting, and follow-ups.
3. Support Analytical Laboratory Management and oversee quality for analytical testing in pre-clinical and clinical trials.
4. Write, review, and approve SOPs, controlled documents, deviations, CAPAs, change controls, and investigations.
5. Participate in regulatory inspections, vendor qualifications, and reassessments for GCLP and GLP activities.
6. Assist in managing regulated equipment and supporting Early Development GLP studies.
7. Provide back-up support for local archive management.

Skills

1. Bachelor’s degree in Biological Science or comparable qualification (B.Sc or above).
2. Demonstrated knowledge of global regulations and guidelines applicable to the analytical testing in clinical trials and under animal rule (such as ICH, FDA, CFR, EMA, OECD).
3. Minimum 7 years of experience in QA or in quality-oriented work supporting analytical testing for clinical trials.
4. Experience in developing audit and/or quality oversight strategies in GxP areas.
5. Experience of preparing for and hosting regulatory inspections.
6. Knowledge of applied risk management and the review of continuous risk management.
7. Demonstrated strong analytical, problem-solving, and decision-making skills.
8. Demonstrated experience in managing projects.
9. Fluency in written and spoken English.

Boost Our Team

Become the trusted QA Expert to our R&D QA team in the Global Quality 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 through to post-marketing, to secure regulatory requirements and expectations.

Our team is embedded in a larger quality organization, dedicated to accompanying Bavarian Nordic through an exciting phase of new products, markets, and business areas.

You will be reporting directly to the head of R&D QA and be part of a team of Global Quality Assurance Staff located in Germany, Denmark, and the US that are supporting GCP, GLP, GCLP, and Pharmacovigilance, providing opportunities for cross-functional collaborations and interesting development opportunities.

We offer
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. We offer a chance to work in an international company with unique technology and a dedicated workforce. We offer the opportunity to be 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. We offer a comprehensive benefits plan and a competitive compensation package.

For us, it is all about improving and saving lives together
We are a fully integrated vaccine company focused on developing, manufacturing, and commercializing life-saving vaccines, and one of the largest pure-play vaccine companies in the world. You will be part of a global team of more than +1600 dedicated employees with diverse backgrounds and viewpoints, who are bound together by our commitment to protect lives every day.

Caught your interest?
We look forward to receiving your application via our recruitment system if you are interested in the position. Just click the Apply-Button on the right side of the page and you will be redirected to our application form.