Experienced Quality Assurance supporter in Drug Product (DP) Manufacturing

Looking to make a real impact in Quality Assurance? Join our DP QA team at the new filling facility in Hillerød. You'll be crucial in the operational startup, fulfilling core quality processes and engaging in tech transfer projects. We’re seeking a dedicated individual ready to enhance QA processes and support our facility’s success.

About the Role

In the DP Quality Assurance role, you will handle daily quality issues and support optimizations within the production. Alongside your core QA work for DP operations, you will support technology transfer initiatives to onboard customer products and processes into our DP facility.

This role provides an exciting opportunity to help shape our QA processes and define quality standards in the DP area as the team develops in the coming years. If you're ready to contribute to and grow within this dynamic environment, we encourage you to apply.

About the Team

Our Drug Product QA team, led by Maria Louise Olsen, currently consists of eight team members and is part of the QA organization, reporting to the Associate Director for Drug Product & Finished Goods.

We are in a formative stage, establishing our quality values and defining processes as we transition into our new DP QA operational roles.

As we embark on this journey, the team is energized and focused on  bringing processes under control and adapting to our start-up phase. We prioritize high-quality standards and GMP compliance through close collaboration with our stakeholders. Our team is engaged in both DP QA operational activities, batch release and the QA approval of equipment, utility, and facility validation documentation.

We work with international QA teams to ensure a proactive and cooperative approach across all initiatives. Joining us means contributing to a dynamic and evolving environment where your impact on quality assurance is both valued and essential.

Job Tasks

Your key responsibilities include:

• Provide QA oversight for the DP production by performing quality walks, support process confirmations and physical presence during Aseptic Process Simulations.
• Review and approve incidents, CAPAs and change management records, SOPs and related risk assessments.
• Drive QA-led enhancement projects and support other projects driven by other departments.
• QA support in tech transfer project for bringing new products from existing or new customers.
• Review and approve Batch Production Records.
• Approve critical Facility and Utility alarms.
• Support inspection readiness and participate in partner audits.

Qualifications needed

Qualifications

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

Professional qualifications

• Master's degree in pharmacy, chemical engineering, or a related field.
• Minimum of 5 years' experience in a QA role within the pharmaceutical industry.
• Experience with formulation, filling and/or visual inspection processes and aseptic production is a plus.
• We positively evaluate profile with experience in batch review
• Proficiency in English, both spoken and written.
• Well-versed in GxP guidelines and quality systems knowledge.

Personal qualifications

As a person, you bring openness and energy to your tasks and interactions with colleagues. With a self-starting attitude, you possess a flexible and dynamic approach to challenges. You combine a detailed, analytical approach with pragmatic problem solving, without compromising on quality.

Application

If you are interested and ready to take the next step, please upload your CV and cover letter at your earliest convenience. We will conduct interviews on a rolling basis. Even if you don't meet all the criteria but believe you can contribute meaningfully to our team, we encourage you to apply. We encourage you to bring your full self to work every day, as we value everyone’s unique talents, diversity, and strengths through mutual trust. So just be you!

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 a competitive compensation and benefits package. 

FUJIFILM 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 identity 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.