GMP Compliance Specialist

at  Fujifilm Diosynth Biotechnologies

Do you thrive by maintaining the vital role of maintaining GMP Compliance as well as driving continuous improvement initiatives to achieve operational excellence?
Then hopefully you will join our dedicated FGM Operations Support Team as our new GMP Compliance Specialist colleague and embark on our great journey of expanding our Finished Goods Manufacturing (FGM) capabilities and partnering with new and exciting companies.
We are looking for new team members to be part of this journey with us!
Your New Role
You will be performing both administrative tasks but also being present at shop floor for e.g. Quality Walks, handling of issues on the labelling and packaging lines and being a constructive contributors in collaborations with different stakeholders.

Your daily tasks

• Provide daily support to the shop floor operations, ensuring compliance with GMP standards and regulatory requirements.
• Represent FGM as a Subject Matter Expert (SME) on projects, investigations, and other initiatives, offering valuable insights and guidance to ensure adherence to GMP principles.
• Implementation of Corrective and Preventive Actions (CAPA), driving resolution of non-conformances and promoting a culture of quality and compliance.
• Drive continuous improvement projects aimed at enhancing operational efficiency, reducing waste, and optimizing processes within the FGM Operations Support team and Shop floor.
• Create and revise GMP documents and ensure compliance across all processes.

Skills & Talents, we hope you possess

• A bachelor’s degree in, Manufacturing Engineering, Pharmaceutical Sciences, or a related field, providing a solid foundation for understanding GMP principles and practices.
• Proven experience in a GMP-regulated environment, with a strong understanding of regulatory requirements and quality standards. Preferably from a Finished Goods Assembly, Labelling and Packaging area.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams. (Communication in both English and Danish is required)
• Demonstrated ability to lead and drive change, with a proactive approach to identifying opportunities for improvement and implementing sustainable solutions.
• Detail-oriented mindset with a passion for ensuring compliance and upholding the highest standards of quality in all operational activities.

We Hope You Are
curious of nature and meet and greet people with a smile and have a can-do attitude. You work with humility and respect for the people around you. You are flexible, and able to prioritize tasks to meet defined timelines. You work structured with a quality mind-set and enjoy working independently and proactive in a dynamic entrepreneurial environment.
Your New Team of specialists
The Operations support team consists of 7 highly skilled colleagues supporting FGM with a mixture of process, equipment, and GMP knowledge. We are dedicated to supporting each other and collectively owning GMP compliance.
We engage in a wide range of responsibilities and tasks, contributing to a dynamic and challenging work environment. You will work in very close collaboration with the colleagues on the FGM shop floor, but also across the organization – Manufacturing Science, Maintenance and Quality among others. We aim to always be curious about the current processes and strive to make an impact on how to work even smarter in the Finished Goods Manufacturing Area
We are team players and people who like details without losing sight of the big picture. The work environment is international. We keep a high pace and focus on a vital work life balance while having fun. We put a strong emphasis on psychological safety through trust and empowerment within our teams and hope that this is something that speaks to you as well.
Application
Has this sparked your interest? Then please apply now and be part of our mission to deliver high-quality products to our Partners and Patients worldwide.
Please upload your CV and cover letter as soon as possible as we screen candidates on a continuous basis. For questions, please contact Manager Tinna Buhl phone +45 28101491
FUJIFILM Diosynth Biotechnologies is a world leading Contract Development Manufacturing Organization (CDMO) serving customers in the pharmaceutical industry – from pre-clinical investigations to commercial GMP production. Our overall mission is to “Advancing Tomorrow’s Medicines” and we like to invite you to be part of our journey.
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.
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.
FUJIFILM Diosynth Biotechnologies Denmark (FDBD) 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.
About Us
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.

• Provide daily support to the shop floor operations, ensuring compliance with GMP standards and regulatory requirements.
• Represent FGM as a Subject Matter Expert (SME) on projects, investigations, and other initiatives, offering valuable insights and guidance to ensure adherence to GMP principles.
• Implementation of Corrective and Preventive Actions (CAPA), driving resolution of non-conformances and promoting a culture of quality and compliance.
• Drive continuous improvement projects aimed at enhancing operational efficiency, reducing waste, and optimizing processes within the FGM Operations Support team and Shop floor.
• Create and revise GMP documents and ensure compliance across all processes