Description

Janssen Pharmaceutica NV is recruiting for a QA Associate (CAR-T), located in Beerse, Belgium.

In the Distribution Center Beerse, we have a complex and dynamic environment that supports the entire J&J supply chain with product flows and storage of both clinical and commercial products. This includes one of the latest product introductions within J&J, specifically CAR-T (CARVYKTI).

Are you looking for a new challenge and are interested in new product technologies, combined with the challenges of a global distribution center, while maintaining a high compliance profile? Then we look forward to getting to know you!

In this role, you will be providing quality oversight for daily activities related to the CAR-T processes in DC Beerse. You will act as a liaison with other quality organizations to standardize practices, requirements and procedures to increase quality and compliance and champion increased awareness of quality related concerns.

Key Responsibilities:

As SME, the employee will provide decision-making, guidance and support on the following topics:

 Act as QA DC lead for different quality processes such as non conformances, change control, quality agreements,.. for CAR-T related topics

 Review and approval of new and updated procedures

 Provide QA oversight of set-up, implementation and hyper-care for new processes

 Align and benchmark with other quality organizations involved in the CAR-T flow to ensure efficient and compliant processes

 Act as spokesperson for DC QA related to CAR-T specific topics, questions and inspections

 Act as SME for DC Beerse for GTP-related topics and requirements

 Perform QA release activities in EU2 SAP for inbound CAR-T patient materials

Qualifications

Education:

 You have a Master's degree in a technical / chemical / pharmaceutical area or equivalent through experience.

Experience and Skills:

Required:

 You have 1 to 5 years of working experience in a GMP/GDP regulated environment and have knowledge of the GMP/GDP regulations .

 Fluent in verbal and written communication in English and Dutch.

 You have a strong ownership and quality mindset. You are able to deliver on commitment timelines.

 You are able to work with a diverse network of stakeholders and have constructive relationships with strategic partners.

 You are willing to learn and develop new skills in a constantly evolving environment.

 You are not afraid to challenge the status quo and use a critical approach.

Preferred:

 High-level understanding of the applicable GTP-regulations

 Experience in working with Trackwise, TruVault, SAP Europe2 and/or eWM is an advantage

What is in it for you?

We are an energetic, dynamic team in an innovative environment with room for personal and professional development. You will have the possibility to gain experience in a variety of tasks with focus on your talents.

We offer with this opportunity an attractive salary package including extra-legal benefits such as meal vouchers and medical insurance.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]