QA GCP Auditor
Genmab’s QA department is expanding, and we are looking for a QA GCP Auditor with GCP and clinical trial experience. The role involves internal and external QA activities and audits of Genmab’s clinical activities to ensure full compliance with GCP and our quality system.

Quality assurance of clinical activities
As a QA GCP Auditor you will take part in assuring that Genmab’s clinical activities are performed in compliance with GCP regulations.

You will conduct QA audits covering all clinical activities: clinical processes and documentation, clinical departments as well as clinical investigator site audits and audits of clinical research organizations and facilities across the world.

You will interact internally with clinical development on a variety of projects or initiatives related to the conduct of clinical trials. You will also provide guidance and assistance to ensure Genmab sustains efficient systems in support of GCP operations.

Finally, you will conduct internal and external training on SOPs/guidelines to ensure that our personnel have the appropriate training and understanding of the GCP regulations.

Experience with GCP and auditing
You have experience with GCP and clinical trial regulations from your previous positions as e.g. QA professional, GCP auditor or Clinical Trial Manager/Clinical Research Associate in the pharmaceutical or biotech industry. You hold a relevant degree, but most importantly you have experience with GCP and/or QA auditing techniques.

Strong communication and organization skills are essential and so are an eye for details and the ability to work with people to achieve solutions. You are fluent in English, and you are flexible and have a good sense of humor. Your solid experience and personal initiative together with a high degree of independence and professionalism will give you a key position in Genmab’s QA department and a chance to contribute to developing procedures and competencies.

Application and contact
Please mark your application “QA GCP Auditor/IGR” and send it to Genmab A/S, Toldbodgade 33, PO Box 9068, DK-1253 Copenhagen K or to job@genmab.com. For further information regarding the position, please contact Associate Director, QA, Dorthe Bruun or Senior Manager, Human Resources, Ida Grønborg at +45 7020 2728.