QA Equipment Professional – Drug Product Manufacturing

Would you like to be crucial in our operational startup? Executing core quality processes and engaging in tech transfer projects as the QA responsible for overseeing commissioning and approving qualification documentation?

Then we hope you are a dedicated professional ready to join us and enhance QA processes and support our facility's success.

Your New Role

You will handle daily quality issues and be the QA for DP support and process equipment as well as facility and clean utility.

Your responsibilities will beside core QA tasks include supporting to tech transfer projects for changes or implementation of new equipment.  Additionally, you'll work on optimization projects and help address any areas where QA support is needed.

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.

Your Key Responsibilities Could Include:

• Review and approve incidents, CAPAs and change management records.
• Conduct quality walks to ensure compliance.
• Drive QA-led enhancement projects and support other projects driven by other departments.
• QA approval of equipment maintenance plans and validation protocols.
• Review and approve Risk Assessments.
• Approve critical Facility and Utility alarms.
• Support inspection readiness and participate in partner audits.

Your Skills & Talent

• 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 equipment qualification.
• We positively evaluate profile with experience in aseptic production.
• Proficiency in English, both spoken and written.
• Well-versed in GxP guidelines and quality systems knowledge.

We hope you are

Energetic and independent team player with an open mind while thriving in a very dynamic environment.

Even if you don't meet all the criteria but believe you can contribute meaningfully to our team, we encourage you to apply.

Your New Team & Department

Our Drug Product QA team, led by Maria Louise Olsen, currently consists of seven 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 new DP QA operational roles.

As we embark on this journey, team members are energized by 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 and the QA approval of equipment, utility, and facility validation documentation.

We work with international QA teams for, ensuring 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.

Our environment is international and informal, emphasizing psychological safety through trust and empowerment, a high pace, and a vital life balance with plenty of fun.

Application

If you are interested and ready to take the next step, please upload your CV and cover letter in English at your earliest convenience. We will conduct interviews on a rolling basis. If you have any questions, feel free to contact our DP QA Manager, Maria Louise Olsen, at marialouise.olsen@fujifilm.com.

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 https://fujifilmbiotechnologies.fujifilm.com/

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.