GxP Lead Auditor

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 quality and audit team, enjoying the rumble of an airplane, experiencing various cultures and work with many different stakeholders and suppliers? Then we might have the job you are looking for! We’re currently looking for a dedicated QA spirit for our audit team!

Follow Your Genki to FDB

The work we do at FUJIFILM Diosynth Biotechnologies (FDB) has never been more important—and we are looking for talented candidates to join us. We’re growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drive—what FDB calls Genki. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At FDB, you determine what’s possible.

Our Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities and technologies to manufacture advanced biologics. As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.

About the Role

Through your sound judgement and risk-based approach, you’ll ensure our vendors/suppliers live up to the relevant legislation (GxP, medical devices, etc.), through onsite and virtual audits, assessments and questionnaires. Some audits and questionnaires will involve training colleagues and other experts who you will learn from. Further you will perform both internal audits and supplier audits.

You will be based at our manufacturing site in Hillerød in our activity based working environment and spend much of the time traveling and with our vendors/suppliers and internal stakeholders.

About the Team/Area

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, we are driven by our curiosity, humor and commitment to the patient. We’re there for each other, always ready to lend a hand.

Job responsibilities

Your primary tasks will be:

• Managing and leading internal audits and supplier audits
• Peer-reviewing colleagues’ audit reporting
• Supporting the qualification process in onboarding new suppliers and supporting vendor management activities
• Managing, preparing and maintaining Supplier TrackWise records
• Using your experience to support/mentor junior auditors on audits, guidelines and performance
• Identifying potential risk, areas of improvement and trends from various audits/ industry and communicating recommendations to management
• Supporting and participating in customer audits and regulatory inspections and activities

Qualifications

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

Professional qualifications

• You have a relevant scientific background (BSc or MSc degree within life science, IT)
• 5-10 years of experience with GxP audits and stakeholder management
• Lead auditor certification or proof of lead audit experience. Preferably you have practical experience with EU GMP, cGMP and IT audits from diverse positions within the biotech/ pharmaceutical industry
• Willing to travel to various countries (app. 40-50%)
• We are an international company and fluency in English is required
• Fluency in Danish is preferred

Personal qualifications

You approach tasks and colleagues with openness and great energy. You possess an analytical mindset and are used to work independently yet be a team player when it is needed and 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 or yourself and the company, then you might be just the candidate, we are looking for!

Your application

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. So apply today and upload your CV and cover letter