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 working 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 shies 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 whom 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, 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
• 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 risks, 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:

• 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 (approx. 40-50%)
• We are an international company and fluency in English is required
• Fluency in Danish is preferred

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 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 of 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 at +45 4194 9919. So apply today and upload your CV and cover letter.

FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina, and College Station, Texas, USA. We use our skills, dedication, and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.

Our site in Hillerød, Denmark, brings together expertise, capabilities, and technologies to manufacture advanced biologics. The large-scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late-phase and commercial use. We commenced 6 billion DKK projects to double our manufacturing capacity and to add fill-finish to the site.

We offer the chance to be part of a global workplace where passion, drive, and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone, no matter their background or gender, has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.

We aim to foster a collaborative, innovative, and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.

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.