We seek an experienced cGMP Specialist to lead audit readiness for Facility Management. You will act as the Subject Matter Expert for Facility Management compliance, ensuring sustained inspection readiness, robust documentation, and effective CAPA management across cleanrooms, cleaning/disinfection, gowning, pest control, maintenance and supplier oversight.
The role includes close collaboration with QA, Production, Regulatory, EHS, and external partners, and active participation in customer and authority inspections.
The role
The Facility Management Compliance Group holds compliance responsibility for building maintenance, cleaning, gowning inventory, and pest control, as well as compliance support for strategic Facility projects.
In close collaboration with internal stakeholders (Facility Contract Management, QA, Production, EHS, Regulatory) and external service partners, you will ensure that the Facility Management Compliance function is always inspection-ready without compromising daily operations. You will act as the cGMP SME for Facility Management, lead our audit readiness program, actively participate in customer audits and regulatory inspections (e.g., Danish Medicines Agency, FDA), and ensure effective follow-up on observations and CAPAs. You enjoy challenging the status quo, simplifying where possible, and elevating the compliance level through continuous improvement.
Your responsibilities
Qualifications
About the area and the team
Facility Management & Security is an integrated part of the EOS organization in FDBD.
We provide high, stable service and support a “best place to work” culture. We operate site-wide and collaborate broadly. Our daily work environment is open, friendly, and characterized by humor and trust, and we prioritize a healthy work–life balance as well as social activities.
You will join our Facility Management Compliance Group of seven dedicated specialists.
You will thrive here if you value quality, patient safety, and results, work independently and systematically, and are motivated by creating inspection-ready processes and documentation. The position offers flexibility and the possibility to work from home when on-site presence is not required.
Application
Does this sound like you? Then please submit your CV and a motivated application letter no later than Sunday 19th April 2026. However, as we will be interviewing on a continuous basis, then please submit your documents sooner rather than later.
Working at FUJIFILM Biotechnologies
We offer a competitive compensation package in a site/company growing rapidly, with many opportunities for individual growth, we also offer access to fitness and an attractive canteen.
FUJIFILM 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 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.
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 Biotechnologies Denmark is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, 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.
For over 30 years, FUJIFILM Biotechnologies' 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.
We aren't simply a workplace. FUJIFILM Biotechnologies a community and 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: https://fujifilmbiotechnologies.fujifilm.com/careers/
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