Do you enjoy working with internal continuous improvement and process optimization and with many different stakeholders and suppliers in an international environment?

Then we hope you would like to be part of our outstanding supplier quality and audit team as we are currently looking for a new dedicated QA spirited colleague!

Your New Role

Through your sound judgement and risk-based approach, you’ll ensure our vendors/suppliers live up to the relevant legislation (GxP, medical devices, etc.), through onsite and virtual audits, assessments and questionnaires. Some audits and questionnaires will involve training colleagues.

Further you will perform both internal audits and supplier audits.  As we strive to continuously improve and optimize the way we work, your role equally includes optimizing and challenging our procedures.

You will be based at our manufacturing site in Hillerød in our activity based working environment and spend around 10% of the time traveling to our vendors/suppliers and internal stakeholders.

Main Tasks:

• Drive and participate in ongoing continuous improvement activities within the team and together with internal stakeholders
• Managing and leading internal audits and supplier audits
• Peer-reviewing of colleagues’ audit reports
• Supporting the qualification process in onboarding new suppliers and supporting vendor management activities
• Managing, preparing and maintaining Supplier records in our global systems
• Support improvement, management and maintenance of procedures and work instructions for Supplier Management and Internal auditing
• Identifying potential risk, areas of improvement and trends from various audits/ industry and communicating recommendations to management
• Supporting and participating in customer audits and regulatory inspections and activities

Your Skills & Talent

• You have a relevant scientific background (BSc or MSc degree within life science, IT)
• 5-10 years of experience with GxP audits and stakeholder management
• You have knowledge and experience with Continuous Improvement – e.g. Lean and Six Sigma toolbox
• Lead auditor certification or proof of lead audit experience. Preferably you have practical experience with EU GMP, cGMP and IT audits from diverse positions within the biotech/ pharmaceutical industry
• Willing to travel to various countries (app. 10%)
• Knowledge of TrackWise and/or Veeva would be preferred but not a must
• Fluency in English is required
• Fluency in Danish is preferred

We hope you are

An energetic and analytical team player with a can-do attitude and a keen eye for stakeholders while thriving in a very dynamic environment.

Your New Team & Department

You’ll join a great, expanding, hard-working and self-managed team of competent colleagues. We are a team of 12 experienced individuals covering a variety of tasks, we are driven by our curiosity, humor and commitment to the patient. We’re there for each other, always ready to lend a hand.

The work environment is international and informal. We keep a high pace and focus on a vital work balance while having fun. We put a strong emphasis on psychological safety through trust and empowerment and hope that this is something that speaks to you as well.

Your application

If we have sparked your interest then please upload your CV and cover letter in English as soon as possible, as we screen candidates on a continuous basis and call in for interviews.

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://fujifilmbiotechnologies.fujifilm.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 paid.