QC Document Coordinator – Temporary Position

at  Fujifilm Diosynth Biotechnologies

We are looking for a candidate who can help us drive and coordinate a major task in which documents need to be aligned across our site in Denmark (FDBD) and new site in the US (FDBN). This role is based in Denmark and coordination will happen via teams/zoom (no travel expected). Internally the role is referred to as a FDBX document coordinator.
The FDBX document coordinator is expected to be self-driven, which means you are comfortable in assessing if a document update is required or not on your own and understand when to escalate in case of uncertainty. You must be calm and collected when interacting with stakeholders to ensure plan is aligned, be good at listening to stakeholder needs while at the same time balance those needs against the timeline and clearly communicate the expectations.
The FDBX document coordinator must have excellent communication skills in English, as you must coordinate between stakeholders locally at FDBD and stakeholders including the Project Manager located in FDBN. In addition, the role requires a flexible approach and creative thinking as plans and priorities may change quickly in a busy environment. You must be comfortable driving and adhering to challenging timelines with stakeholders to ensure content updates are provided to meet deliverable completion dates.
Furthermore, the role requires a detailed and systematic approach to identify whether documents require: simple revisions, revisions by SME, and/or a new document needs to be written and an existing document retired. The FDBX document coordinator will need to provide regular status updates to the Project Coordinator located at FDBN and communicate in a timely fashion any challenges, issues, or delays with solutions to reduce impact of delay.
The role is a temporary position for 1 year tied to the FDBX document project. Notice due to time zone differences some meetings can be expected in the afternoon to allow for interaction with US counterparts.

Key tasks for the job:

• Help us achieve the process of converting relevant local documents to our global FDBX documents thereby allowing us to align two major sites for the future across the FDB network.
• Coordinate with stakeholders across several different laboratories and locations while having an eye for detail. E.g. role must be able to assess when a document can be converted to FDBX with no changes and when SMEs needs to be involved.
• Take ownership of our Master Control (our Document Management System) process overview and package execution for documents in scope.
• Project Planning and Communication. E.g. what is the order of execution and how does it fit with the business schedule?

Qualifications and Education

• Optimally you have experience working with or in a laboratory setting to allow for smooth communication with SMEs from the laboratory.
• With the current ongoing site expansion in scope, you must be able to handle many tasks and changing priorities in a busy GMP environment.
• Almost all tasks require buy-in from stakeholders, so you possess excellent communication and collaboration skills.
• You have experience with cGMP and have written/updated SOPs in the past.
• You have an educational degree within Natural Sciences, Health and Medical Sciences, Pharmacy, Lab Technician or equivalent
• Fluency in English is required as we are an international company with English as the corporate language.

About our Quality Control department
Our QC department at site Hillerød consists of approximately 200+ employees divided into several supporting- and testing teams, QC Projects is one of the supporting teams. In QC we strive towards a OneQC team spirit where we help each other across teams not only to reach our goals but also to support a high level of collaboration and possibilities for personal development. The pillar in our QC department is our employees – our success is only possible due to competent and dedicated colleagues, who wants to make a difference for QC, our site, our customers, and patients all over the globe. As a leading CDMO company we, in QC, are obligated to continuously improve our way of working creating a dynamic and inspiring environment with huge individual co-decision making due to our flat organizational structure.
Your application
If you find the job interesting and it fits your qualifications, please upload your CV and cover letter. Applications will be evaluated continuously as they arrive. For questions, please reach out to QC System Support Manager Stephan Spence, +4541949796.
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 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 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.

• Help us achieve the process of converting relevant local documents to our global FDBX documents thereby allowing us to align two major sites for the future across the FDB network.
• Coordinate with stakeholders across several different laboratories and locations while having an eye for detail. E.g. role must be able to assess when a document can be converted to FDBX with no changes and when SMEs needs to be involved.
• Take ownership of our Master Control (our Document Management System) process overview and package execution for documents in scope.
• Project Planning and Communication. E.g. what is the order of execution and how does it fit with the business schedule