GxP Specialist Supplier Quality Management

Do you want to join an advanced biotech company that develop and manufacture some of the leading biological products on the market today and for the future? Then join Fujifilm Diosynth Biotechnologies, a biotech company that aspires to be the leading CDMO within our areas of expertise.

Do you like to put things in structure, manage stakeholders and are you curious of nature. Then we might have the job you are looking for! We are currently looking for a GxP Specialist Supplier Quality Management for our team.

The team for you to join

You will be part of a great, hard-working and self-managed team of competent colleagues. We are a team of 5 experienced individuals covering a variety of tasks, we are driven by our curiosity, humor and commitment to the patient. We support each other and help where we can.

What would your role look like?

You will ensure, through your sound judgement that vendor change notifications are assessed and processed in the right way. Meaning assessing the impact and handling such impact in the change control system. You will help setup and run various processes. Coordinate PQR inputs for our customers. Manage complaints for our suppliers. Basically you will interact with our suppliers, internal colleagues and customers. You will be based in Hillerød together with the team.

Who are we looking for?

A person with a good sense of humor and charm, who can work independent yet be a team player when it is needed. Experience with GxP requirements and stakeholder skills. Preferably you have practical experience with EU GMP and cGMP from various positions within the biotech/ pharmaceutical industry.

You must have/ be:

  • BSc/ MSc degree within natural & life science
  • 3-8 years of GxP experience
  • Skills to structure cases and follow up
  • Willing to interact with suppliers, internal colleagues and customers

​What we offer you

Great colleagues in a newly established team. A challenging position with an established CDMO, who is looking to grow. All the challenges you can ask imagine that will help you grow.

If you need more information

Contact person Kristian Byrialsen, Head of Regulatory Affairs, Supplier Quality Management and Audits. +45 26 24 33 46.

Please apply online

Deadline for applications is 20th March 2020, applications will be reviewed continuously and relevant applicants will be interviewed continuously. So apply today.

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FUJIFILM Diosynth Biotechnologies is an industry-leading biologics Contract Development and Manufacturing Organization (CDMO) with locations in Teesside, UK, RTP, North Carolina, College Station, Texas and Hillerod, Denmark. FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems.

The Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities and technologies to manufacture advanced biologics. Our large scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. The facility for medical device assembly, labeling and packaging manufactures advanced delivery systems and ensures required labeling and secure packaging of the therapies for patients worldwide.

The site also houses quality control laboratories, warehouses, and a number of organizations, supporting the manufacturing activities: process science, supply chain management, engineering and quality assurance.

Our people are what make FUJIFILM Diosynth Biotechnologies standout. We recruit talented and passionate people, each playing a vital role in our success. At FUJIFILM Diosynth Biotechnologies, you will gain hands-on experience in an industry-leading biologics contract development and manufacturing organization. You will work with highly-skilled and experienced professionals of different nationalities and backgrounds, engaging in challenging work by delivering solutions for the bio-pharmaceutical industry.

We aim to foster a collaborative, innovative, diverse and rewarding environment, where it is possible to develop and learn. We pursue our fullest potential as individual contributors and team members. As part of our team, every one is a valuable contributor in the advancement of tomorrow’s medicine. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.