Quality Assurance Officer

Byondis is an independent Dutch biopharmaceutical company, based in Nijmegen, that focuses on developing innovative medicines against cancer and autoimmune diseases. We are driven by one goal: to develop new treatments to improve the standard of care for patients. Within the Byondis CMC department we develop our processes from cell line development up to Drug Product and we have our own in house GMP manufacturing facilities to produce monoclonal Antibodies (mAbs) and Antibody Drug Conjugates (ADCs) for our clinical needs.

Your Role
Are you a Quality Assurance professional who wants to work in collaborative team in which you can grow and develop your skills?

You will join our quality assurance team, committed to providing quality oversight and guidance to our production of clinical supplies, advancing the progress of Byondis. As QA Officer you will perform accurate and timely review of production documentation from both Manufacturing and Quality Control departments and prepare release of our products. This will include Master and Executed Batch Records, raw data records, deviations, changes and Corrective/Preventive Actions. In this role you also support the technology transfer of new processes from R&D to GMP manufacturing in close collaboration with the project teams and secure the GMP documentation flow within the QA group ensuring document traceability and status. You will report to the head of the QA department.

What do you need to succeed in this role?
A quality mindset and the capacity to apply this in a dynamic environment for First in Human and subsequent clinical GMP productions.  A team player taking responsibility for their own and the team’s work, with good collaboration and communication skills. You are result-oriented and use proactivity and creativity as your methodology to find solutions. You are self-motivated which enables you to work with a high degree of independence.

• Bachelor/master level in biotechnology related studies, life sciences or equivalent
• At least 5 years’ experience in quality assurance, preferably in the biotechnological industry. Prior experience in a production environment is an advantage.
• Knowledge of current Good Manufacturing Practices (cGMP) and data integrity requirements in the (bio)pharmaceutical industry towards operational processes within Quality Assurance, Quality Control and Manufacture.
• Accurate and consistent document review capabilities
• A can-do attitude, hands-on mentality embracing cross-functional collaboration.
• Outstanding verbal and written communication skills in English and (preferably) Dutch
• Affinity with computerized systems (like ERP and QMS)

Benefits and well being

Besides a competitive salary, we offer you a dynamic working environment at our state of the art campus in Nijmegen.  Our values as integrity, authenticity, entrepreneurship, quality and trust are very highly regarded. We also offer an excellent pension scheme, 30 days annual holidays based on a fulltime position and we organize several company events throughout the year.

Join Byondis and create the future you want, today

Contract hours: 32-40 hrs/week, preferably fulltime
Salary: depending on experience
Location: Nijmegen
Applicants must be nationals of a Member State of the European Union or hold a valid work permit for the European Union

For further information, please contact François Hugen, HR Advisor, at tel. +31 (0)24 679 5234 or by email; recruitment@byondis.com. If you are interested in joining Byondis in this challenging position, we welcome your application via the apply button. We'll keep searching until we find the best candidate or please send in your application before October 25, 2024.