Delegated QP for QA Finished Goods Manufacturing

We are looking for an experienced delegated Qualified Person (QP) to join our successful QA team supporting Finished Goods Manufacturing (FGM). We are handling disposition of batches, we have the Quality Oversight of FGM, and we are part of Tech transfers of new products into the facility.

Follow Your Genki to FUJIFILM Diosynth Biotechnologies
The work we do at FUJIFILM Diosynth Biotechnologies (FDB) has never been more important—and we are looking for talented candidates to join us. We’re growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drive—what FDB calls Genki. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At FDB, you determine what’s possible.

About the Role
As a delegated QP in the QA FGM team you will support activities related to Finished Goods Manufacturing (FGM). You will assess the quality of FG batches and be involved in batch disposition, and you will be part of assessing deviations related to the manufacturing process to ensure timely release of batches. You will have a close collaboration with different stakeholders in FGM and supporting functions as well as other QA functions to ensure flexibility and to align our Quality mindset for the site.

Additionally, in this role you will also be involved in Tech transfers of new products into our facility.

Having an informal work environment, strive to have a lot of fun, being a team player, keeping calm during periods with competing priorities are highly valued attributes for this role.

About the Department/Team
QA Finished Goods department at FUJIFILM Diosynth Biotechnologies in Hillerød consists of 21 employees, covering all QA activities related to Finished Goods Manufacturing. QA FGM is one team out of two sister teams.

You will be part of the QA FGM team consisting of 12 dedicated employees accountable for the Quality Oversight of the operations and equipment and facility of FGM.

We support with a mixture of process and equipment knowledge. Supporting each other in the daily routine tasks as well as projects to be executed - all done through very open and honest communication within the team and in very close collaboration with our colleagues in FGM and supporting functions. The work environment is informal, where we strive to have fun, while we support the daily operations and the ongoing projects making sure that results are delivered within the dedicated timelines. We take pride in working with all types of stakeholders on all levels of the organization.

About the Role
Your primary tasks will be:

• QA Review and disposition of Finished Goods batches, ensuring the batch has been manufactured and tested in accordance with GMP regulations and quality agreements.
• Quality oversight of FGM processes.
• QA handling of deviations and changes and support projects related to FGM processes including tech transfers of new products.
• Support continuous improvements related to QA processes.
• Support the development and maintenance of the Quality Management System.

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

Professional qualifications

• Master’s Degree (MSc) in pharmacy, medicine, veterinary science, pharmaceutical chemistry and technology, chemistry, biology or similar.
• +2 years of experience with GMP and experience from QA and/or manufacturing experience from the pharmaceutical industry.
• Experience as delegated QP is an advantage.
• Good communication skills and fluency in English and a high level of business perspective.

Personal qualifications

You are a team player who is motivated by working in a dynamic environment with a strong focus on providing support to both colleagues and stakeholders. You have a positive and pragmatic attitude with focus on delivery times. You take ownership of your work and feel comfortable by independently resolving issues. You have solid interpersonal skills and enjoy cooperating with colleagues from different cultures, on all levels and from different functions with the focus of building a strong collaboration and trust in your network.

You possess excellent communication and collaboration skills – and understand the need for working closely together in your own team but also across teams – helping each other deliver on common goals.

Lastly, if you see yourself as a high performing team player who is ambitious on behalf or yourself and the company, then you might be just the candidate, we are looking for!

Application
Are you interested? Then we urge you to please upload your CV and cover letter as soon as possible as we will be doing interviews on an ongoing basis. Should you have any questions, please feel free to reach out to Manager in QA FGM, Kirsten Hasselstrøm at [email protected] or mobile 41703540.

FUJIFILM Diosynth 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 benefit package.

FUJIFILM Diosynth 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 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.

Location: FDBD Hillerod