Groundbreaking Biotech - Towards Better Treatment

Genmab is an international biotech company who develops human antibodies for the treatment of chronic and life threatening diseases, with a strong focus on cancer.

We are currently looking for a Clinical Quality Assurance Manager to join QA at our headquarters in Copenhagen.

Job contents:

• Plan for - Perform, and follow-up on Quality Audits within GCP regulated areas both internally and externally
• Represent QA in clinical Project Groups or clinical sub groups and participate in cooperation with partners and contractors as appropriate.
• Provide internal QA support in the organization
• Prepare/coordinate and participate in GCP inspections performed by national authorities
• Participate in the development and maintenance of the Quality Management System (QMS)
• Participate in gaining and maintaining expert knowledge about new GXP legislation, guidelines and practices including informing relevant parts of the Organization
• Participate in the training and education of employees in the various GCP guidelines and regulations
• Ensure that the company’s clinical trials are conducted in compliance with clinical protocols, GCPs and other regulatory requirements
• Leads and manages effective communications and relationships with CRO´s
• Ensure that validated computer systems including risk assessments within Genmab are maintained in a validated state as the QA responsible   

You will refer to the Director of Quality

Professional profile:

You are a pharmacist or have a master’s degree in relevant natural science. You have a minimum of five (5) years experience in the pharmaceutical or biopharmaceutical industry and a minimum of five (5) years experience in a Quality function (QC or QA). In addition, you have the following qualifications:  

• Extensive GCP experience and auditing skills
• Experienced with conducting clinical trials
• Confident with using your experience to get faster forward
• Excellent understanding of QA principles, industry practices, and standards with demonstrated ability to apply these to GCP operations
• Good understanding of Quality Systems and regulatory expectations
• Hands-on experience with computervalidation in the pharmaceutical industry
• Fluency in English and preferably Danish/Scandinavian (meetings will often be in Danish)

Personal profile:  

• Excellent verbal and written communication skills
• Demonstrated ability to manage multiple tasks, prioritize work and define steps needed to achieve project outcomes
• Strong attention to detail with strong documentation and coordination practices
• An independent work-approach and good at building solid professional relations to collaborators and business partners
• Ability to work in an often hectic working environment
• Good at team work but also enjoying to take decisions on your own.  

In Genmab we are ready for changes and act fast so you thrive in a work environment where multitasking, independence and self motivation are required.   

In Genmab we are proactive, flexible and take initiatives. We pursue joy and positivity so your contributions in this respect will be valued. Our working environment is international and we appreciate good spirits, humor and good collaboration skills.

The company language is English and in this function communication internally as well as externally is an important asset in our daily work so you need to be proficient in English and have good communication skills.

Influence, development and work-life balance

Genmab is a fairly small biotech company with a short chain of command, so you will have opportunity to influence your own work as well as your personal and professional development. You will also have flexible working hours and conditions.

Please mark your application “Clinical Quality Assurance Manager” and send it to Beirholm Search, Baghuset Trunnevangen 2, 2920 Charlottenlund, or e-mail kontakt@beirholmsearch.dk. If you have any questions, please contact Jane Juel, Director, Administration & HR at +45 70202728, or Hanne Beirholm at +45 39403927.

Genmab is an international biotech company who develops human antibodies for the treatment of chronic and life threatening diseases, with a strong focus on cancer.

We are currently looking for a Student Worker to join IPR & Legal departments at our headquarters in Copenhagen.

The Job
As Student Worker in our IPR & Legal departments you will assist with archiving documents in our Legal contract database and perform other administrative tasks.

Qualifications
You are probably a student at university or other institution of higher education. You are responsible, meticulous, and detail-oriented, and you find it very important that tasks are solved as promised, and in the quality agreed.

We expect you to have a good command of English in reading and writing as well as good computer skills at user level.

Other info
Genmab is a fairly small biotech company, and the atmosphere is very free-and-easy.
You will have great opportunity to influence your own work, and also with flexible working hours and conditions.

The work time will be approximately 5-10 hours a week upon further agreement.

Please mark your application “Student Worker, IPR & Legal” and send it to Genmab A/S, Bredgade 34, P.O. Box 9068, 1260 Copenhagen K, Denmark, or via email to job@genmab.com – preferably as a Word document. If you have any questions, please contact HR & Administration Associate Sanne Byskov Klinke, at +45 7020 2728.