Lead Auditor
FUJIFILM Diosynth Biotechnologies
Dato: for 2 uger siden
By: Hillerød, Region Hovedstaden
Kontrakttype: Fuld tid
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
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 Diosynth 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 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.
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
- 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
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 Diosynth 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 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.
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