GMP Supporters for our Compliance Support team in Manufacturing Support

FUJIFILM Biotechnologies; Hillerød; On-site; DKK 450,000 - 700,000; Full time

Benefits offered by this job

Fitness facilities

Canteen

Job summary

FUJIFILM Biotechnologies Denmark is seeking a Quality & Compliance professional to partner with production in a fast-paced GMP environment. You will handle deviations, CAPAs, and changes, perform GEMBA walks, and keep SOPs sharp to secure timely batch release.

You will work with the Manufacturing Support team in Hillerød to apply data-driven analyses, drive quality improvements, and participate in audits to support continuous GMP/QMS operations.

Qualifications

• Educational background is preferably a Bachelor within engineering, science, pharmacy or similar.
• Experience with cGMP and pharmaceutical manufacturing
• Preferably 2+ years in the industry.
• Familiar with complex quality processes in regulated GMP areas.
• Analyzing data and creating overviews with data-driven patterns.
• Excellent business communication skills in Danish and English.

Responsibilities

• Collaboration with production on site and GMP-related tasks such as changes, SOP & Work Instructions creation & maintenance.
• Writing deviations using SPS with A3 tool; facilitate A3 meetings and investigate root causes.
• Daily shopfloor presence in production and classification of deviations.
• Prepare, write CAPAs for board presentation and ensure timely batch release.
• Participating in audits/inspections and supporting GMP training.

Skills

Quality & Compliance

GMP

Data analysis

Communication (Danish & English)

Education

Bachelor in engineering, science, pharmacy or similar

Tools

SPS with A3 tool

Job description

This is an exciting opportunity for those who love working with Quality & Compliance in a high pace production environment - a role that is essential to our License to Operate.

You’ll partner with production to drive high-quality compliance: handle deviations and changes, perform GEMBA/shopfloor walks, and keep SOPs sharp.

Bring your cGMP experience and data-driven mindset to shape how we work with Quality & Compliance in a fast-paced, international environment. Help us secure timely batch release, pass audits, and continuously improve together.

About The Role

You’ll collaborate with managers and operators to ensure our GMP level. A key part of your role will be understanding the QMS system and completing all GMP/QMS related tasks in a timely manner and of high quality. Your main tasks include handling deviations and changes (delimitation, corrective & preventive actions, qualification, etc.), doing GEMBA walks, writing and updating SOPs, etc.

Job Responsibilities (not limited to)

Your Initial Primary Tasks Will Be

• Collaboration with production on site
• GMP related tasks such as changes, SOP & Work Instructions creation & maintenance, etc.
• Writing deviations using SPS with A3 tool
• Facilitate A3 meetings and investigate root causes
• Daily Shopfloor in production
• Classification of deviations picked up on shop floor
• Preparing, writing CAPAs for board presentation
• Closing deviation in time for batch release
• Participating in audits/inspections where relevant.
• General support with compliance related tasks
• Drive and coordinate quality improvements.
• Support GMP training and contribute to the understanding of GMP in the department.
• Participation in ad hoc projects.

Qualifications

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

Professional Qualifications

• Educational background is preferably a Bachelor within engineering, science, pharmacy or similar.
• Experience with cGMP and pharmaceutical manufacturing
• Preferably 2+ years in the industry.
• You are familiar with complex quality processes and have experience from regulated GMP areas.
• Analyzing data and creating complicated overviews and visualizing data driven patterns.
• Excellent business communication skills, both in Danish and English.

Personal Qualifications

We’re looking for someone who takes responsibility and ownership - someone who acts and is proactive, who thrives in dynamic setting where things go fast. You can easily tackle challenges, and your positive mind and 'can-do' attitude helps you thrive in challenging situations, ensuring effective collaboration and smooth operational workflows. You enjoy optimizing production efficiency. You are structured and responsible, with excellent Quality & Compliance skills. As a problem-solver with a solution-focused mindset, you excel in building strong teamwork and relationships. Lastly, if you see yourself as a highly performing team player who is ambitious on behalf of yourself and the company, then you might be just the candidate we are looking for!

About The Department / Team

The Manufacturing Support department comprises three sub-departments - Dispensary, Campaign Support, and Solution Preparation - with approximately 150–160 full-time employees supporting both Up- and Downstream production. We ensure that solution mixes, columns, and materials are available on time and of the right quality. You will have the opportunity to help shape how we work with Quality & Compliance. Within this department, a dedicated team of five people manages timely, high-quality completion of deviations and keeps Work Instructions and SOPs accurate and up to date, alongside other Quality & Compliance activities.

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 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.