QA Specialist

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

You will join our team of quality specialists, connected by mutual respect and a deep-rooted commitment to secure the quality of our innovative clinical products. The responsibilities encompass a wide range of tasks, with focus on maintaining and further improving our Pharmaceutical Quality System and secure effective implementation of new procedures throughout the GMP organization while cultivating the quality culture. Therefore, you will have direct contact with the GMP related teams like Manufacturing, Quality Control, Supply Chain, Maintenance and IT departments. In addition, you will provide guidance on regulations and GMP, represent QA in project teams and participate in (internal) audits. You will also participate in review and approval of GMP documentation as well as handling of deviations, CAPAs and changes. You will report to the head of the QA department.

What do you need to succeed in this role?

Ownership of activities with a mindset on precision and quality of your own and your colleague's work. A natural team player with an attitude to collaborate and communicate as well as being flexible to act in a fast changing and demanding environment. 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.

• MSc degree in Biotechnology or other relevant life science field
• At least 5 years’ experience in a biopharmaceutical GMP environment. Operational experience is preferred.
• An excellent quality mindset, creative and curious attitude and eagerness to continuously improve processes.
• In depth knowledge of cGMP standards within the biopharmaceutical industry towards operational processes with a focus on early clinical activities.
• You have excellent social skills, good communication in English and preferably Dutch and possess a collaborative approach
• Skilled in Lean/Six Sigma practices
• A can-do attitude, hands-on mentality embracing cross-functional collaboration.
• Able to identify opportunities for optimization driving Right-First-Time all the time
• A flexible and pragmatic approach

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 a pension scheme, 30 days annual holidays based on a fulltime position and we organize several company events throughout the year.  

Contract hours: 32-40 hrs/week, preferably fulltime

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 1 March 2024

Applicants must be nationals of a Member State of the European Union or hold a valid work permit for the European Union.