Pharmaceutical Quality System (PQS) Associate

Can you ensure that our products or services provided to our customers meet the required quality standards?

And do you thrive with looking for ways to improve and promote quality on both a local and global scale?

Then maybe you would like to be our new Quality Assurance, Pharmaceutical Quality System (PQS) Associate colleague!

Your New Role
Your primary driver is to support, develop, and maintain a firm Pharmaceutical Quality System (PQS), as well as support the business leading preparation for customer audits and regulatory inspections where we demonstrate our strong PQS.

You'll be encouraged to continuously identify best practices both within FDB and externally, serving as a vital connection for sharing innovative strategies and ideas.

Main responsibilities:

• Ensure adequate quality systems are implemented across the business to meet regulatory and customers’ requirements.
• Support creation and maintenance of quality assurance documents for all our quality subsystems.
• Be a key support for audits and inspections at the Hillerød site including follow up on observations, actions, process improvement opportunities.
• Interface with Business Process Owners (BPO’s) to implement quality system strategies and plans to facilitate continuous improvements of the PQS
• Interface with Regulatory Affairs and Business Process Owners to develop robust compliance processes.
• In collaboration with Regulatory Affairs, interpret and implement quality assurance standard
• Assures ongoing compliance with quality and industry regulatory requirements
• Maintain professional working knowledge of relevant regulations, guidance documents, and standards
• Identify best practices within the company, and outside of FDB, and serve as a conduit for best practice sharing.
• May periodically be assigned specific projects across the company, which align with the company’s strategic plan.

Skills & Knowledge, we hope you possess

• bachelor’s degree in engineering, science, operations or business within the biopharmaceutical sector.
• Minimum ten (10) years of experience in regulated industries with at least five (5) years in pharmaceuticals or medical device. PQS experience in a regulated industry required.
• Working knowledge of Veeva EDMS and TrackWise preferred.
• Comfortable leading preparation for audits and inspections.
• Good understanding of the continuous improvement and Lean principals
• Experience in use of Microsoft Word, Excel, and PowerPoint

We hope you are
A detail-oriented team player with the ability to see the bigger picture and envision step-change scenarios/conceptual/process skills and strong skills in presenting, coaching, and communication, fostering understanding and growth; as well as being confident and adept at engaging with individuals across all levels of the organization, building meaningful connections and collaboration.

Your New Team & Department
The Pharmaceutical Quality System department (PQS) is a team of 11, motivated professionals who manage a variety of QA tasks in relation to the Pharmaceutical Quality System (PQS), including maintain and improving quality documents, user administration of our quality applications (i.e.: Veeva, TrackWise), support improvement projects, host customers audits and regulatory inspections.

You will be part of a very competent team that works with a high level of independence and influence on their daily work. We are driven by our commitment to the patient. As a team, we support each other, and value open and honest communication both within the team and with internal and external stakeholders.

We truly believe in team success at FUJIFILM Diosynth Biotechnologies and therefore it is important that you balance team and individual responsibilities; Exhibit objectivity and openness to others' views; Give and welcome feedback; Contribute to building a positive team spirit; Put success of team above own interests; Able to build morale and group commitments to goals and objectives; Support everyone's efforts to succeed.

The work environment is international and informal. We keep a high pace and focus on a vital life balance while having fun. We put a strong emphasis on psychological safety through trust and empowerment within our teams and hope that this is something that speaks to you as well.

Your application
Does this sound interesting? Then please upload your CV and cover letter as soon as possible, as we will continuously invite relevant candidates for job interviews. The job advertisement will be removed when the right candidate has been identified.

FUJIFILM Diosynth 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://fujifilmdiosynth.com/

FUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, 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