GxP Specialist

Would you like to join an advanced biotech company that develops and manufactures some of the leading biological products on the market today and for the future? FUJIFILM Diosynth Biotechnologies is a biotech company aspiring to be the leading CDMO within our areas of expertise.

If you’re interested in being part of our outstanding supplier and internal auditing team, be involved in, coordinate and managing our supplier and audit documentation, engage with internal stakeholder across sites and suppliers, strengthen and ensure quality compliance through change controls and related quality systems? Then we have the job you are looking for! We’re currently looking for a dedicated QA spirit for our audit team!

About the Team
You’ll join a great, expanding, hard-working and self-managed team of competent colleagues. We are a team of 22 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.

About the Role
Through your sound judgement and risk-based approach, you will help ensure that both our internal stakeholders and suppliers comply with the relevant legislation (GxP, medical devices, etc.), thanks to your proactive quality mindset and hands-on approach.

You will be based at our manufacturing site in Hillerød in our activity based working environment.

Job responsibilities
Your primary tasks will be:

• Manage and coordinate updates of our Approved Supplier List in applicable IT systems with internal stakeholders, including:
• Manage, prepare and maintaining Supplier TrackWise records and supplier contact and quality data
• Coordinate change controls and supplier changes related to supplier records, approved supplier list and supplier quality agreements
• Support and coordinate with auditors on supplier data and TrackWise records
• Review and approve minor audit observation responses and audit CAPA's
• Support and coordinate TrackWise workflows and maintain relevant supplier process, GxP records and archiving
• Support and manage/coordinate change controls, quality agreement revisions, assessment of vendor changes and impact assessments
• Support and provide coordination to auditors and audit planning, following upon audit observations
• Support and ensure follow up on KPI and QMR
• Manage and ensure quality system procedures updates and driving updates

Qualifications
We are looking for a candidate with the following background and skill sets:

Professional qualifications

• You have a relevant scientific background (BSc or MSc degree within life science)
• 3-5 years of experience with GxP QA and supplier management
• We are an international company and fluency in English is required
• Fluency in Danish is preferred
• Strong interpersonal skills
• Positive mindset

You approach tasks and colleagues with openness and great energy. You possess an analytical mindset and are used to work independently yet be a team player when it is needed. You understand the importance of involving stakeholders in your daily work. If you see yourself as a high performing team player who is ambitious on behalf of yourself and the company, then you could be the candidate, we are looking for!

Your Application
If your qualifications meet our requirements, and we have sparked your interest in joining us, please apply for this position.

We will continuously invite relevant candidates for job interviews and will close the position as soon as we have found the right candidate.

If you have any questions, contact Henrik Thrane, Associate Director, Supplier Quality Management and Audits. +45 4194 9919.

About FUJIFILM Diosynth Biotechnologies

We are 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. Learn more at https://fujifilmdiosynth.com/

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 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.

Location: FDBD Hillerod