Coordinator in Quality

at  Fujifilm Diosynth Biotechnologies

Are you our new coordinator within Quality? Do you enjoy working with Planning & Forecasting, Contract Laboratory Organization (CLO) management, Reference standard & Control management - then join our Data Management team within Quality in our site in Hillerød
The Team
You will be part of the Data Management Team within Program Quality Management. Program Quality Management is part of the Quality organization and consists of QC Program Management, QA Program Management, Stability, and the Data Management. Our team is characterized by informal work culture, strong team spirited and a multicultural team.
The position
You will be the point of contact for CLO´s used within Quality Control (QC) ensuring the relationship and making sure contracts are in place. Your responsibilities will include monitoring of inventory levels, providing status to management and facilitating the timely delivery of products to customers. In this role we are looking for the candidate who can operate independently and as part of a team with both internal and external partners. The ideal candidate has a high degree of business acumen as well as process insight to drive, facilitate, and manage stakeholders across the entire business with authority and charisma. In this position you should expect to build-up a strong insight to our business, and a strong network both internally and with various customers.

Your tasks and responsibilities will include but not be limited to:

• Lead, coordinate and facilitate planning meetings to ensure high performance of QC service delivery.
• One of the primary business contacts for QC Contract Laboratories. Support the generation of contracts and amendments to these (Quality Agreement, Statement of Work, Master Service Agreement) in collaboration with QC and Quality Assurance (QA).
• Monitor inventory levels of reference standards & controls and providing status internally and to customers.
• Participate in Operational meetings to ensure the smooth running of normal operational activities.

You will work closely with internal stakeholders in QC but also with stakeholders from other functions to ensure high performance for every customer. We work in a busy and dynamic environment where we support biologics Drug Substance (DS) production as well as the global release of commercial products (DS/DP) for our global network of clients.
Your Talent
We are looking for the right candidate who has a meticulous eye for details, thrives in coordinating and prioritizes collaboration with multiple stakeholders in a fast paced environment.

Qualifications and competences:

• Well experienced Laboratory technician or a Degree in Natural Science
• Preferred 5 years relevant QA or QC experience from the pharmaceutical industry,
• Knowledge of GMP Quality Systems
• Experience with planning or coordination.
• As a person, you are organized with an attention to detail but are still able to keep an overview.
• You are service minded with excellent verbal and oral communication skills.
• You have an ability to work independently and are self-driven.
• You thrive in a changing environment.
• You enjoy multitasking.

If you do not meet all the requirements, we encourage you to offer alternative experience that you think would be beneficial in this role.
Application
Has this sparked your interest? Then we urge you to please upload your CV and cover letter as soon as possible as we will be doing interviews on an ongoing basis. We will take down the advert when the right candidate has been identified.
For questions or doubts, please do not hesitate to contact Associate Manager for Data Management Kari Jacobsen on +45 51906615.
Working at FUJIFILM Diosynth 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 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.

• Lead, coordinate and facilitate planning meetings to ensure high performance of QC service delivery.
• One of the primary business contacts for QC Contract Laboratories. Support the generation of contracts and amendments to these (Quality Agreement, Statement of Work, Master Service Agreement) in collaboration with QC and Quality Assurance (QA).
• Monitor inventory levels of reference standards & controls and providing status internally and to customers.
• Participate in Operational meetings to ensure the smooth running of normal operational activities