Customer Program Quality Associate

Do you have QA experience in manufacturing (Drug Substance/Drug Product/Finished Goods)? Are you interested in ensuring the right Quality level for our customers and keep them updated on the manufacturing of their products? Then you might be the key person we are looking for!

Come and join the Program Quality Management team for Manufacturing (PQM MFG) at FUJIFILM Biotechnologies and play an important role in the relationship with our customers. With a fast-expanding site, our team is growing to support our increased number of customers. The PQM MFG team is accountable for the communication of all quality related topics affecting customer’s programs for production of Drug Substance, Drug Product and Finished Goods. The communication is based on the responsibilities defined in Quality Agreement (QUAG).
 

About the Position

We work with various biopharma companies, which means each project  brings a unique set of challenges. As a Customer Program Quality Associate, you are a link between our customers and our FDB team.

You will be involved in different quality related topics affecting customer’s programs and make sure customers are informed and involved to feel confident in our collaboration. You will interact with highly skilled personnel to support your communication on complex activities. You will take part in identifying opportunities to improve systems and practices and provide direction to our manufacturing group as well as technical development teams and our customers. You represent our company: our mission of advancing tomorrow’s medicine, our passion for collaborating with our partners for life, and our dedication to seeing every project through with the highest amount of integrity and impact.

Job Responsibilities

Your primary tasks:

• Perform impact assessments of change controls and deviations towards Quality Agreement requirements
• Be the primary point of contact to customers regarding assessment and communication on deviations, change controls, CAPAs and various ad hoc requests
• Prepare KPI data for Quality Management Review meetings and other reporting structures
• Establish, develop and maintain department documents: customer presentations, SOPs and participate in our internal continuous improvement activities
• Ad hoc tasks

About the Department/Team

The Program Quality Management (MFG) team consists of 8 highly skilled and dedicated team members with broad experience within pharmaceutical manufacturing. The team is embedded in the Quality organization under Program Quality and provides quality support to production of engineering, clinical, PPQ and commercial batches in large scale Drug Substance manufacturing, Drug Product manufacturing and Finished Goods manufacturing.
 

About the Quality Department

Our Quality department at our site in Hillerød consists of approximately 350 employees divided into various QA and QC teams. In Quality we strive to 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 in our Quality department is our employees – our success is only possible due to competent and dedicated colleagues, who wants to make a difference for Quality, our site, our customers, and patients all over the globe. As a leading CDMO company we, in Quality, 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 Biotechnologies Denmark (FLBD) 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 and the possibility to work from home. FLBD also has a canteen arrangement incl. Friday brunch and monthly afternoon cake, just as we have a “bell ringing” tradition when reaching important milestones.

Professional and Personal Qualifications

• Bachelor’s or master’s degree in Biochemistry, Biology, Biotechnology, Pharmaceutical Sciences, or similar
• Interest and knowledge of GMP and quality systems
• Minimum of 2 years of relevant QA experience
• You approach tasks and colleagues with openness and great energy
• You possess a structured mindset and understand the importance of involving stakeholders in your daily work
• You are a self-starter and have a flexible, dynamic approach to work
• You are service-minded with excellent written and verbal communication skills
• Fluency in English is required, as English is our corporate language

At FLBD we put people first and we always look for candidates with the right combination of personality and skills. FUJIFILM 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 work-life balance. We are many different nationalities and personalities at FLBD and for us to succeed we all need to focus on communication, take responsibility, organize, execute various tasks, solve problems and display great interpersonal skills.     

Application

Has this sparked your interest? Then we urge you to submit 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 Program Quality Management, Manufacturing, Annelise Olsen +45 41945471

FUJIFILM Biotechnologies is a global leader in biologics contract development and manufacturing Organization (CDMO), partnering with innovative biotech and biopharma companies to transform healthcare. With locations in Denmark, the UK, and the USA, we support every stage of our customers’ product lifecycle, from breakthrough cures to life-saving vaccines.

Our success starts with our people—their passion drives progress, innovation, and impact. Join a diverse, inclusive workplace that values collaboration, fosters growth, and empowers future generations. Together, we’re enriching communities, protecting the environment, and reimagining healthcare’s potential.

Shape the future with us—your drive meets boundless opportunity here https://fujifilmdiosynth.com/

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 pai