Vacancy List Details

Vacancy List Details

QA Manager, GLP

Copenhagen, Denmark

Genmab is now searching for a QA Manager in the GLP area.

Genmab has a robust pipeline of innovative human antibody therapeutics and a number of strategic partnerships are already in place with international blue chip companies. The company is continuing its positive growth and development, striving towards its goal of improving the lives of oncology patients with unmet medical needs.

Job content
You will be part of the QA department at the headquarters in Copenhagen and you will report to the Senior Director, QA. You will collaborate with colleagues across the organ-ization, with the overall goal of developing new and innovative medicine for patients.

You main tasks are:

• Quality oversight of establishing and maintaining our Bioanalytical GLP laboratory in Genmabs Dutch Site in Utrecht
• Actively support the goal to certify our GLP lab (EU-regulation) 
• Provide Quality oversight, and actively contribute to Training and Quality Advise to Lab personnel and Management
• Quality oversight of GLP-CRO’s 
• Plan, conduct and follow up on CRO audits
• Review of Standard Operating Procedures and GLP study documents
• Provide guidance on quality topics within Non-Clinical Safety
• Review and approve facility documents including computersystem validation 
• Maintain and share an updated knowledge within OECD GLP  

Expected travel: 40 days/year

Professional profile
Ideally you hold a Master’s Degree in Life Science (Pharmacist, Human Biologist, Biolo-gy, Biochemistry etc.)  You have minimum 5 years of experience from a similar position in the pharmaceutical industry within antibodies and biological drugs. You are fully proficient in English at a professional level, both written and spoken. You have hands-on experience with a certified GLP laboratory and maintain your deep knowledge within the OECD GLP in a strong network. You thrive in the advisor role and also as trainer within your field of expertise.   

Personal Profile 
You are independent and a self-starter. You are good at establishing and maintaining relations across the organization and collaborators, and you strive to find the best and most sustainable solutions. You are detail oriented and you have a thorough and sys-tematic approach. You have a positive attitude and thrive in an often hectic and changing environment. You enjoy working in an environment where colleagues are respected for their knowledge, skills, and contribution, and receive acknowledgement for achieving results as an individual and as part of a team.
Genmab is a biotech company with a short chain of command. You will have the oppor-tunity to influence your own work as well as your personal and professional develop-ment.

At Genmab we are ready for challenges and they act fast so you thrive in a work envi-ronment with a “can do attitude” and have the necessary resilience and self-motivation required to make a maximum impact. 

Our Company 
At Genmab we strive to improve the lives of cancer patients by creating and developing innovative antibody therapeutics.  With two marketed products and a robust pipeline of differentiated antibodies, Genmab is working to transform the treatment of cancer.  

We are motivated by knowing that our work has the potential to make a real difference for cancer patients and their families.  Our culture values innovation, determination, teamwork, and integrity. We work cross-functionally and internationally as one global team, while individuals and local teams have the autonomy to drive the development of innovative products and technologies that could provide next generation cancer treat-ments. 

Please refer to our homepage for more information about working at Genmab.

For more details about the job or the company, please contact HR & Administration Associate, Sanne Byskov Klinke or Senior Director, QA, Charlotte Tvermoes Rezai at +45 70 20 27 28. All applications must be in English and are treated confidentially.

Deadline for applicants: Interviews will be conducted on an ongoing basis
Location: Copenhagen, Denmark
How to apply: