Senior QA for QC Specialist

Join the QA for QC Team at FUJIFILM Biotechnologies in Hillerød and work as a QA specialist supporting our QC laboratory in this newly created position. As our production site grows, QC is expanding which requires more Quality Oversight. We are looking for a senior QA specialist who would like to be part of a positive, engaged and supportive team.

About the Team

The team currently consists of 12 people and is further a part of a larger QA organization which provides quality support to production of batches in drug substance manufacturing, drug product filling and Assembly, Label and Pack. QA for QC is a dynamic team with close collaboration with multiple internal stakeholders and QA colleagues.

About the Role

As a Senior QA for QC Specialist with 5+ years of relevant experience, you will be the primary QA contact for the QC laboratory across all its activities. Your responsibilities will vary based on qualifications and interests, including reviewing and approving QC-relevant documents, changes, deviations, instrument qualifications, tech. transfers and quality approval of work orders and alarms, as well as ad hoc assignments. Additionally, you will actively engage with QC to enhance compliance and ensure quality oversight.

Primary Responsibilities

• Provide QA support to QC; review and approve QC related documentation

• Assess and approve changes

• Oversee tech transfer protocols, reports and related quality topics

• Review and approve instrument qualification

• Quality approve work orders and alarms

• Ensure procedures and methodologies are followed, and that appropriate,complete documentation is captured and reported. Act as quality partner by providing guidance, training and ad hoc support to stakeholders

• Represent QA for QC on assigned QC- related projects

• Take part in local and potential future global alignment tasks within QA for QC

• Maintain internal training level and keep up to date on cGMPs, regulatory requirements as well as on global procedures, guidelines, policies, frames, and specifications

Qualifications

• Collaborative mindset with a willingness to integrate into the team and organisation

• Well-versed in GxP guidances and knowledge of quality systems

• Ability to work in a very dynamic environment and thrive building the road as we go

• Self-driven, proactive and excellent communication skills and good at creating structure

• 5+ years of work experience or educational background enabling an understanding of the complexity of manufacturing biologics.

• Preferably experience overseeing quality of deviations, changes, instrument qualifications and method tech. transfers

• Fluent spoken and written English

Education

The right mindset, strong deliverables and practical experience are key. Educational background is secondary, but could be within the following areas (thought not prerequisite); Bachelor's or Master's degree in natural science (e.g. Pharmacy, Biotechnology, Biology, Engineering, or similar)

If you do not meet all of the above mentioned criteria, but believe you have something to contribute with and still find the position interesting, then please submit your application.

FUJIFILM 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

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.

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.

About Us

FUJIFILM Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina, Toyama, Japan 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 site in Hillerød, Denmark, brings together expertise, capabilities and technologies to manufacture advanced biologics. The large scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. We commenced 6 billion DKK projects to double our manufacturing capacity and to add fill finish to the site.

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.

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.