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.
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.
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.
FUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
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What We Do
For over 30 years, FUJIFILM Diosynth Biotechnology’s mission has been advancing tomorrow’s medicine. As a CDMO, we work in partnership with the most innovative biopharma and biotech companies across the world who are reimagining healthcare’s potential. We help to accelerate their progress, expand their capabilities, streamline their processes, and strengthen their innovation. So when our customers’ potential cures, vaccines, biologics, and accomplishments make strides – or even become new realities for patients – we know our work, our manufacturing expertise, and our partnership helped make it happen.
FDB isn’t simply a workplace. It’s a place of passion – a place of what we call Genki. A place where diverse perspectives and people come to life. Where opportunity for growth has no end. Where passion is followed, discovered, and nurtured. Where the energy is undeniable, enthusiasm is pervasive, and drive is infectious. All of our global locations burst with curiosity, inspiration, and extraordinary purpose.
So as we continue to grow our teams, our global locations, and our capabilities, Genki will always be our cultural tie. That’s why we’re always looking for passionate, mission-driven people who want to commit their life’s work to enabling better outcomes for patients and their families.
For a full listing of jobs that will propel, inspire, and fulfill you, please visit: fujifilmdiosynth.com/careers/
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