Senior Quality Assurance Associate for Drug Substance

Are you ready to play a key role in developing life-saving medicines? Do you have experience in quality assurance and thrive in challenging environments? Then we hope you’re our new colleague!

At FUJIFILM Biotechnologies, you’ll collaborate with some of the most innovative biopharma companies worldwide. You’ll learn from dedicated scientists, engineers, and manufacturing experts who are deeply committed to improving patients’ lives.

Drug Substance Quality Assurance is seeking a Senior Quality Assurance Associate with the following skills:

• 5+ years of experience in drug substance manufacturing, Good Documentation Practice, Good Manufacturing Practice, quality systems, and legislation/regulations
• A relevant university degree (e.g., Biotechnology, Pharmacy, Medicine, Chemistry, Biology, or similar)
• A detail-oriented team player thriving in a changing environment who sees the bigger picture and envisions change.

What we do (in close collaboration with stakeholders)

• Review and approve batch records
• Review and approve documentation related to automation and equipment (maintenance, modifications, and alarm handling)
• Oversee campaign changeovers—ensuring equipment readiness between products
• Update controlled documents (e.g., procedures and work instructions)
• Review and manage deviations, CAPAs, and change controls
• Conduct and review risk assessments
• Quality oversight: production walks, housekeeping, & process confirmation
• Continuous improvement projects related to what we do
• Partners for technology transfers when introducing new products from existing or new customers

About the department

You’ll thrive in Drug Substance Quality Assurance if you enjoy a dynamic environment, close collaboration, and work that spans manufacturing operations and optimization projects. Our growing department currently includes approximately 55 employees.
We prioritize teams over hierarchy. Daily interactions and mutual support foster both professional and personal development across teams. We encourage a Gemba (“go and see”) mindset when working with stakeholders to deepen understanding and foster cross‑functional collaboration.

We value diversity and encourage you to bring your full self to work—your unique talents and strengths make us better.

Interested?
Please upload your CV and cover letter as soon as possible. We review applications and conduct interviews on a rolling basis.

Working at FUJIFILM 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 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 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 e-mail, 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.