Pharmaceutical Quality System (PQS) Senior Associate

Are you passionate about upholding quality standards in a rapidly evolving industry?
Do you have the expertise to drive excellence and innovation in pharmaceutical quality systems?

Then we really hope you’ll be our new colleague!

Your New Role
As a Quality Assurance, Pharmaceutical Quality System (PQS) Senior Associate, you'll ensure that our products and services consistently meet quality standards. You have the ambition to enhance and promote quality on both local and global scales.

Your main responsibility is to lead/support preparations for customer audits and regulatory inspections, demonstrating our strong PQS. You'll create a conducive environment for sharing best practices within and outside of FUJIFILM Biotechnologies.

You will report to the Head of Pharmaceutical Quality Systems.

Key Responsibilities:

• Lead and host customer audits and regulatory inspections at the Hillerød site, including logistics, request handling, and evidence management (front room/back room).
• Coordinate audit/inspection readiness: mock inspections, scripting, SME coaching on inspection etiquette, and data integrity (ALCOA+).
• Lead audit responses: align with stakeholders, prepare and track CAPA plans through closure; ensure effectiveness verification and trend reduction.
• Interact with regulatory agencies in connection with inspections and post-inspection actions/CAPAs.
• Collaborate with customers, QA, Manufacturing, QC, Supply Chain, Regulatory Affairs, and Business Process Owners (BPOs) to strengthen compliance processes and implement improvements.
• Support maintenance and continuous improvement of the PQS aligned to ICH Q10 and ICH Q9, including deviation/CAPA quality, change control, risk management, training effectiveness, and SOP lifecycle.
• Ensure ongoing compliance with applicable regulations and standards (EU GMP, Annex 1 where relevant; 21 CFR Parts 210/211 and 11; data integrity principles).
• Monitor regulatory intelligence and drive updates to procedures and training.
• Track and report metrics (e.g., audit closure timelines, CAPA effectiveness, recurrence trends, critical/major/minor finding rates).
• Occasionally manage/lead projects aligned with company strategy.

What You’ll Bring (Must-have):

• Bachelor’s degree in engineering, life sciences, pharmacy, or a related field.
• 5–7+ years of experience in GxP-regulated industries, with direct involvement in audits and inspections within pharmaceuticals and/or medical devices.
• Demonstrated experience preparing, hosting, and responding to customer and regulatory inspections.
• Strong understanding of PQS/QMS frameworks (ICH Q10/Q9, EU GMP, 21 CFR 210/211/11) and data integrity (ALCOA+).
• Proven CAPA management and root cause analysis skills (e.g., 5-Why, Fishbone/Ishikawa, FMEA).
• Excellent communication and stakeholder management under time pressure.

Preferred

• Experience with Veeva Vault (QMS/EDMS) and TrackWise (QMS); familiarity with SAP/QM or similar.
• Exposure to biologics and sterile operations (EU GMP Annex 1).

We Hope You Are

A detail-oriented, communicative team player who can see the bigger picture and drive change. Comfortable leading audit preparations, presenting at all organizational levels, and coaching SMEs.

Your New Team & Department

Your team Our Pharmaceutical Quality System (PQS) team consists of 13 motivated professionals who:

• Manage QA tasks related to the PQS
• Maintain quality documents and user administration for applications (e.g., Veeva Vault, TrackWise)
• Host Quality Management Reviews
• Host Customer audits and Regulatory Inspections
• Support improvement projects across the site

We are a competent, collaborative team with high independence and impact, driven by our commitment to patients. We value open communication, psychological safety, trust, and empowerment. Our international, informal environment keeps a high pace while prioritizing life balance, fun, and engagement.

Your Application
Interested? Please upload your CV and cover letter as soon as possible, as we continually interview candidates and will remove the advertisement once we find the right fit.

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, 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.