GXP Specialist

Would you like to join an advanced biotech company that develops and manufactures some of the leading biological products on the market today and for the future? FUJIFILM Diosynth Biotechnologies is a biotech company aspiring to be the leading CDMO within our areas of expertise.

If you’re interested in being part of our outstanding supplier and internal auditing team, be involved in, coordinate and managing our supplier and audit documentation, engage with internal stakeholders across sites and suppliers, strengthen and ensure quality compliance through change controls and related quality systems? Then we have the job you are looking for We’re currently looking for a dedicated QA spirit for our audit team

You’ll join a great, expanding, hard-working and self-managed team of competent colleagues. We are a team of 12 experienced individuals covering a variety of tasks, driven by our curiosity, humor, and commitment to the patient and quality. We’re there for each other, always ready to lend a hand.

Through your sound judgement and risk-based approach, you will help ensure that both our internal stakeholders and suppliers comply with the relevant legislation (API, drug, medical devices, etc.), thanks to your proactive quality mindset and hands-on approach.

You will be based at our manufacturing site in Hillerød in our activity-based working environment.

Your primary tasks will be:

1. Support and manage/coordinate change controls, quality agreement revisions, assessment of vendor changes and impact assessments.
2. Management and negotiation of supplier quality agreements with suppliers and internal stakeholders.
3. Support maintenance of the approved GMP supplier list.
4. Support and coordinate TrackWise workflows and maintain relevant supplier process, GxP records and archiving.
5. Review and approve minor audit observation responses and audit CAPAs.
6. Support and ensure follow up on KPI and QMR data.
7. Manage and ensure quality system procedures updates and driving updates.

We are looking for a candidate with the following background and skill sets:

1. You have a relevant scientific background (BSc or MSc degree within life science).
2. 3-5 years of experience with GxP QA and supplier/auditing management, project-related work.
3. Fluency in English is required; fluency in Danish is preferred.
4. Strong interpersonal skills.
5. Positive mindset.

You approach tasks and colleagues with openness and great energy. You possess an analytical mindset and are used to working independently yet being a team player when needed. You understand the importance of involving stakeholders in your daily work. If you see yourself as a high-performing team player who is ambitious on behalf of yourself and the company, then you could be the candidate we are looking for

If your qualifications meet our requirements, and we have sparked your interest in joining us, please apply for this position.

We will continuously invite relevant candidates for job interviews and will close the position as soon as we have found the right candidate.

If you have any questions, contact Henrik Thrane, Associate Director, Supplier Quality Management and Audits. +45 4194 9919.