Lead Auditor
Do you thrive in roles that challenge you to identify risks and communicate improvement strategies?
Are you ready to support supplier quality and collaborate with peers for continuous development?
If so, come join us!
Your New Role
With your sound judgment and risk-based thinking, you’ll be key in ensuring our vendors and suppliers adhere to relevant legislation (GxP, medical devices, etc.) via onsite and virtual audits, assessments, and questionnaires. You will also engage in training sessions with colleagues and other experts, fostering mutual learning and growth.
Your responsibilities will include both internal audits and supplier audits. As an organization committed to continuous improvement and optimizing processes, you will have the opportunity to challenge and enhance our procedures, contributing to our collective success.
Based at our manufacturing site in Hillerød, our activity-based working environment supports your role, which includes travel for working closely with vendors, suppliers, and internal stakeholders.
Main Responsibilities:
- Managing and leading internal audits and supplier audits
- Peer-reviewing colleagues’ audit reporting
- Supporting the qualification process in onboarding new suppliers and supporting vendor management activities
- Managing, preparing and maintaining Supplier TrackWise records
- Using your experience to support/mentor junior auditors on audits, guidelines and performance
- 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
- Participate in ongoing continuous improvement activities within the team and together with internal stakeholders
Skills & Knowledge, we hope you possess
- A Relevant scientific background (BSc or MSc degree within life science, IT)
- 5-10 years of experience with GxP audits and stakeholder management
- 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. 30-40%)
- We are an international company and fluency in English is required
- Fluency in Danish is preferred
We hope you are
someone who embraces tasks and interactions with openness and vibrant energy. You hold an analytical mindset, finding the balance between independent work and being a valuable team player when collaboration is key. Understanding the importance of engaging stakeholders in your daily activities shows your commitment to a collective success.
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 life balance while having fun. We put a strong emphasis on psychological safety through trust and empowerment within our teams and hope that this is something that speaks to you as well.
Your application
Has this sparked your interest? Then please upload your CV and cover letter as soon as possible as we conduct interviews on an ongoing basis and will take down the advert when we have found the right candidate.
In case you have any questions, please do not hesitate to reach out to Betina Hilligsøe, [email protected], phone: +45 22 18 32 81
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 paid.
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What We Do
For over 30 years, FUJIFILM Diosynth Biotechnology’s mission has been advancing tomorrow’s medicine. As a CDMO, we work in partnership with the most innovative biopharma and biotech companies across the world who are reimagining healthcare’s potential. We help to accelerate their progress, expand their capabilities, streamline their processes, and strengthen their innovation. So when our customers’ potential cures, vaccines, biologics, and accomplishments make strides – or even become new realities for patients – we know our work, our manufacturing expertise, and our partnership helped make it happen. FDB isn’t simply a workplace. It’s a place of passion – a place of what we call Genki. A place where diverse perspectives and people come to life. Where opportunity for growth has no end. Where passion is followed, discovered, and nurtured. Where the energy is undeniable, enthusiasm is pervasive, and drive is infectious. All of our global locations burst with curiosity, inspiration, and extraordinary purpose. So as we continue to grow our teams, our global locations, and our capabilities, Genki will always be our cultural tie. That’s why we’re always looking for passionate, mission-driven people who want to commit their life’s work to enabling better outcomes for patients and their families. For a full listing of jobs that will propel, inspire, and fulfill you, please visit: fujifilmdiosynth.com/careers/ We created this space on LinkedIn to give people a window into work and culture at FDB. We’re highlighting employees’ passion, current openings, and why it’s never been a more exciting time to join FDB.
