Quality Systems Associate

Auris Health

Auris Health

Quality Assurance
Posted on Tuesday, August 29, 2023


You have a passion for Quality and easily connect with different partners? Then this position is waiting for you!

We as Quality Systems group belong to the Quality organization of Janssen Supply Chain and are responsible to ensure compliance of different quality processes and systems within the Beerse site (including commercial and clinical production, commercial and clinical labs and the distribution center). Additionally, we handle requests from partners and health authorities to support registrations and license renewals.

To strengthen this team, we are looking for a Quality Systems Associate, located in Beerse, Belgium.

Job Responsibilities :

As Quality Systems Associate, you will be responsible for:

· Manage and improve the quality process related to indirect material / service qualification in collaboration with local and global stakeholders

· Handling requests regarding registration support and license renewals (ex: Quality statement, quality questionnaire, certificates, etc.)

· Drives and reports quality metrics in order to continuously monitor and improve the quality process performances and digitalize metrics reporting

· Support different quality processes such as nonconformance, change control, quality agreements, record retention, ….

· Act as SME during internal and external audits for quality system processes



· You have a Bachelor or Master degree in technical / chemical / pharmaceutical area or equivalent through experience.

· You have working experience in a GMP regulated environment and have knowledge of the GMP regulations (e.g., Eudralex Volume 4, 21 CFR Parts 210/ 211)

· Fluent in verbal and written communication in English and Dutch and are able to connect with diverse partners.

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

· You have strong analytical skills and eager to drive the quality organization into a digital future.

What is in it for you?

You will work in a dynamic team in an international and 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.

The employers of Johnson & Johnson value diversity, equity and inclusion. We are committed to forming teams with varied strengths that reflect both the patients and the partners we support. We strive to create an inclusive work environment where our people feel at home and are given the space to realize their full potential.