Vacancy List Details

Vacancy List Details

QA Manager, GMP

Copenhagen, Denmark

Genmab is now searching for a QA Manager in the GMP 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 organization, with the overall goal of developing new and innovative medicine for patients.

Your main tasks are:

- Provide Quality oversight in CMC-project groups and in collaboration with internal and external stakeholders as a QA project manager in the different phases of clinical development
- Build and maintain quality collaboration with contract parties (CMOs) and secure  that relevant agreements/contracts are in place
- Conduct Quality audits within the GMP/GDP, records management and  IT area internally and externally
- Gain and maintain expert knowledge by following new GMP legislation, guidelines and practices and ensure that the information is implemented accordingly
- Active participate in developing, maintaining and improving the Pharmaceutical - Quality System (PQS) within the GMP and GDP area
- Assessing and approve/reject documentation and products
- Handling of deviations, CAPA’s, complaints and assist in product recall
- Act as QP delegate in final batch release
- Travelling: 20 days/year

Professional profile
Ideally you hold a Master’s Degree in Life Science (Pharmacist, Human Biologist, 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 experience within CMC, auditing and QMS and you have been working within different phases of clinical development as well as the commercial stage. Furthermore, you have a strong understanding of quality processes in a global organization.

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 systematic 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 opportunity to influence your own work as well as your personal and professional development.

At Genmab people are ready for challenges and they act fast so you thrive in a work environment 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 treatments.

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

For more details about the job or the company, please contact Senior Consultant Louise Nielsen, Unique Human Capital on M +45 29 74 24 24. 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: Apply here