GMP Supporters for our Compliance Support team in Manufacturing Support

FLBD FUJIFILM Life Sciences Biotechnologies Denmark ApS; Hillerød; On-site; DKK 520,000 - 750,000; Full time

Benefits offered by this job

Competitive pay

Growth opportunities

Fitness facilities

Canteen

Job summary

FLBD FUJIFILM Life Sciences Biotechnologies Denmark ApS in Denmark is seeking a Quality & Compliance professional to ensure GMP level production and timely batch release. You will handle deviations, changes, GEMBA walks, SOP updates, and CAPAs while collaborating with production in a fast-paced, international setting.

The role requires cGMP experience, data-driven analysis, and strong communication in Danish and English, with opportunities to drive continuous improvements and audits.

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.

Responsibilities

• 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.

Skills

GMP knowledge

Deviation handling

SOP writing

GEMBA walks

Data analysis

Quality mindset

Education

Bachelor in engineering, science, pharmacy or similar

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. Your efforts will directly help us meet our goals by ensuring a high compliance level in the department.

Job Responsibilities (not limited to)

• 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

• 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.

We offer an international, informal, and professional environment that values psychological safety, trust, empowerment, good humor, and a healthy work–life balance.

Working at FUJIFILM Biotechnologies

We offer an 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.

• Competitive compensation package.
• Many opportunities for individual growth.
• Access to fitness.
• 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 work across the entire lifecycle of our customers’ products – enabling success throughout.

Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop.

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.

All qualified applicants will also receive consideration without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class.

We are part of the Fujifilm Group, and we all share the same purpose.

Giving our world more smiles.

We bring diverse ideas, unique capabilities, and extraordinary people together to change the world.

We pursue our fullest potential as individual contributors and team members.

We are driven to revolutionize the industry through our Partners for Life mindset, seeking to build global partnerships based on trust with our customers.

Our global teams fully embrace our aspiration of being the leading and most trusted Partners for Life in the biopharmaceutical industry.