QC Program Quality Manager

at  Fujifilm Diosynth Biotechnologies

We are looking for a QC Program Quality Manager who is passionate about Customer Engagement and Program Management. Who shares our passion, drive, and energy – what we call Genki – and wants to be part of the QC PQM team.
About FUJIFILM Diosynth Biotechnologies and our Quality Control Department
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 vision as a company is “Advancing Tomorrow’s Medicines.” This is a goal that we collectively strive towards as an organization, and we look forward to you joining us on this exciting journey.
Our Quality Control (QC) department at site Hillerød consists of approximately 240 employees divided into different support teams and five testing teams. In QC we strive towards a OneQC team spirit where we help and support 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 of our QC department is our employees – our success is only possible due to competent and dedicated colleagues, who want 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.
The culture at FUJIFILM Denmark (FDBD) is key if you ask our employees and besides a competitive salary and bonus package, we offer health insurance, massage and physiotherapy, health check, fitness center, possibility to work from home and most recently we invested in a mobile barista coffee van. FDBD also has a canteen arrangement incl. Friday brunch and monthly afternoon cake, just as we have a “bell ringing” tradition when reaching important milestones. In all, we value a sense of community in the workplace and have implemented traditions and routines that nurture this concept.
The Program/Project Manager structure at FDBD is structured with an overall PM handling direct Customer contact and overseeing Manufacturing activities as well as some QA/ QC Activities. In this role, you will be the QC Program Quality Manager, the title allows for distinction between the QA and QC functions within the FDBD organization.
You will act as the designated QC PQM responsible for an overview of all QC related activities but will also handle and manage the interdependencies between several departments related to and dependent upon QC. This role is deeply rooted in co-ordination and collaboration, the scope is diverse and creates a great opportunity to develop a network across the Organization. As FDBD is growing as a company, we are developing and refining our processes in order to streamline Customer experience. This role allows you to shape our processes and build towards a great collaboration.
About the position
As QC Program Quality Manager, you will be part a of team that currently consists of 5 dedicated employees but will be expanding due to more programs coming in.

Your primary tasks will be but not limited to:

• Learn to identify and support the customers needs and requirements. You will act as the primary QC contact for external customers and partners for all Fujifilm Diosynth Biotechnologies Denmark QC teams involved in the customer collaboration.
• Support initial meetings with customers together with Analytical technology for the Technology Transfer and Quality Control activities from a QC customer perspective.
• Lead, coordinate and facilitate customer meetings to ensure high performance of QC activities
• Operational meetings to ensure normal operational activities
• Quality management meetings where relevant Key Performance Indicators are shared and reviewed
• Support the generation of contracts and amendments to these (Quality Agreement, Statement of Work, Master Service Agreement) together with the global Commercial Development team and Quality Assurance.
• Adhere to the global quality system and support handling of tasks in accordance with Statement of Works and Quality Agreement.

You will be reporting into the manager of QC PQM and be a member of the QC organization.
Professional and Personal Qualifications
The candidate holds a master’s degree in Biochemistry, Biology, Biotechnology, Pharmaceutical Sciences or similar with interest and knowledge of GMP and quality systems with a minimum of 5-10-year relevant QA or QC experience. The ideal candidate comes with a minimum of 5 years of experience preferably from the CDMO/CLO business. You are positive and organized with an attention to detail and still able to keep an overview in a changing environment. You are service minded with excellent verbal and oral communication skills. Fluency in English is required as English is our corporate language.
This role demands that you can operate on both a strategic level with senior executives and to facilitate operational elements in the actual program execution. It requires a personality that demonstrates sufficient business acumen and the ability to quickly learn and gain sufficient process insight to drive, facilitate, and manage stakeholders across the entire business with authority and confidence.
At FDBD we put people first and we always look for candidates with the right combination of personality and skills. FUJIFILM Diosynth Biotechnologies will, as any other modern company, ask our employees for agility and flexibility from time to time but we always make sure to have a controlled and favorable work-life balance. We at FDBD represent e many different nationalities and personalities. In order for us to succeed we all need to focus on communication, taking responsibility, to organize and execute on various tasks, solve problems, and display great interpersonal skills.
Application
Has this sparked your interest? Then we urge you to send an updated CV and cover letter as soon as possible. We will continuously invite relevant candidates for job interviews and will close the position as soon as we have found the right candidate. In case you have any questions, please do not hesitate to contact Head of QC Product Quality Management Rikke Hedegaard +45 91357105.
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.

• Learn to identify and support the customers needs and requirements. You will act as the primary QC contact for external customers and partners for all Fujifilm Diosynth Biotechnologies Denmark QC teams involved in the customer collaboration.
• Support initial meetings with customers together with Analytical technology for the Technology Transfer and Quality Control activities from a QC customer perspective.
• Lead, coordinate and facilitate customer meetings to ensure high performance of QC activities
• Operational meetings to ensure normal operational activities
• Quality management meetings where relevant Key Performance Indicators are shared and reviewed
• Support the generation of contracts and amendments to these (Quality Agreement, Statement of Work, Master Service Agreement) together with the global Commercial Development team and Quality Assurance.
• Adhere to the global quality system and support handling of tasks in accordance with Statement of Works and Quality Agreement