Compliance Officer Adqc

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.

**Your Role**

The department of Analytical Development and Quality Control (ADQC) plays a key role in Byondis’ development and manufacturing because without extensive and accurate measurements, biotechnology-derived medicinal products cannot be designed, improved or applied. That is why we take pride in providing high quality analytical information to ensure the safety and efficacy of our innovative products in patients.

ADQC is responsible for all analytical testing to enable the development, manufacture and use of biotherapeutic products for toxicological assessments and clinical trials. The department develops, qualifies and applies a broad panel of analytical methods to characterize new biological entities such as monoclonal antibodies and antibody drug conjugates. These methods are also used to support the development of manufacturing processes and to perform quality control testing under GMP conditions.

The department comprises a diverse and multidisciplinary team of about 45 people with in-depth knowledge and experience in various analytical areas. We always seek collaboration and we are determined to provide answers rather than test results.

The ADQC department has a job opening for a Compliance Officer. This officer supports all ADQC analytical GMP operations and will be a member of the departmental Release, Stability and Compliance team. Key responsibilities include the following:

- Managing analytical changes and deviations with input from ADQC co-workers, including writing/coordinating comprehensive Trackwise records for all analytical disciplines
- Managing material specifications and release of these materials for the manufacture of clinical materials
- Writing and review of GMP documentation
- Writing or updating (analytical) phase-appropriate GMP procedures (SOPs and WIs related to quality control)
- Reviewing and approving equipment logbooks and data trending reports
- Supervising training records of all ADQC co-workers performing GMP activities
- Supporting GMP inspections and (internal) audits
- First point of contact for ADQC co-workers, QA, E&M and OPS in relation to daily (operational) questions on quality

**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 open-minded and flexible to act in a fast changing and demanding environment. You are result-oriented and use pro-activity and creativity to find solutions. You are self-motivated, which enables you to work with a high degree of independence.
- A B.Sc. level of education (or equivalent based on working experience)_
- At least 3 years of GMP experience in the biopharmaceutical industry
- An excellent quality mindset, curious attitude and eagerness to continuously improve processes
- Good knowledge of GMP regulations within the biopharmaceutical industry
- Experience with deviation and change control in relation with GMP testing
- Experience with GMP inspections and audits is a strong preference
- Technical understanding of analytical methods used for the quality control of biopharmaceuticals
- Understanding of the development trajectory of biopharmaceutical products
- Good verbal and written skills in English
- Excellent communication skills
- Team player

**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 good pension scheme, 30 days annual holidays based on a full-time 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

**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.
- Application deadline:_

18/05/2025
- Expected start date:_

ASAP
- Location:_

Nijmegen
- Company homepage:_
- Office address:_

Microweg 4, 6545CM Nijmegen