FUJIFILM Biotechnologies

Senior Quality Assurance Associate, Drug Substance

FUJIFILM Biotechnologies  •  Kingdom of Denmark (Hybrid)  •  6 days ago
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Job Description

Drive on‑floor quality and deliver results. As the QA for drug substance operations, you’ll drive fast, high‑quality decisions that improve right-first-time, shorten release, and de‑risk tech transfers in a high‑growth environment.

We win as one team: clear goals, open communication, shared learning, and visible impact.

Impact you’ll deliver:

  • Raise performance: improve right‑first‑time
  • Decision authority: approve deviations/CAPAs/change controls; stop/go authority to protect product quality and compliance.
  • Be present on the floor: production walks, housekeeping, and process confirmation with a coaching mindset to improve right‑first‑time.
  • Documentation clarity: streamline procedures and work instructions; keep them usable, audit‑ready, and compliant with current regulations.
  • Lead issues to closure: managing deviations, CAPAs, and change controls; share learnings to prevent recurrence and implement preventive actions that stick, citing relevant regulations/standards.
  • Risk‑based decisions: run practical risk assessments to keep batches moving without compromising compliance.
  • Inspection readiness: act as QA frontline during audits/inspections; present factual evidence and regulatory rationale confidently.
  • Review and approve tasks related to drug substance production; make decisions quickly and explain the “why” to align teams.

What you bring

  • 5+ years in drug substance (API/biologics) manufacturing under cGMP/GDP.
  • Strong working knowledge of applicable GxP legislation and the judgment to apply it on the shop floor.
  • Bias to action, crisp decisions, and the ability to hold the line on quality—while communicating the “why” clearly.
  • Degree in Biotechnology, Pharmacy, Medicine, Chemistry, Biology, or related.
  • Enjoys collaboration, quick huddles, and sharing wins.

Why this role

  • Scale and visibility: contribute across a 55+ person QA team in a high‑growth environment—your impact is seen.
  • Ownership with support: clear decision rights, open doors, and colleagues who back you.
  • Growth and recognition: perform, learn, and progress—we celebrate outcomes and share credit.

Apply now: We move fast with rolling reviews and interviews. Submit your CV and cover letter today.

FUJIFILM Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark; Teesside, United Kingdom; RTP, North Carolina; Holly Springs, North Carolina; and College Station, Texas. 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.

The culture is key if you ask our employees and besides a competitive salary and bonus package, we offer health insurance, massage and physiotherapy, health check, fitness center and hybrid working. Our facility also has a canteen arrangement incl. Friday brunch and monthly afternoon cake, just as we have a “bell ringing” tradition when reaching important milestones.

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.

FUJIFILM Biotechnologies

About FUJIFILM Biotechnologies

For over 30 years, FUJIFILM Biotechnologies' mission has been advancing tomorrow’s medicine. As a CDMO, we work in partnership with the most innovative biopharma and biotech companies across the world who are reimagining healthcare’s potential. We help to accelerate their progress, expand their capabilities, streamline their processes, and strengthen their innovation. So when our customers’ potential cures, vaccines, biologics, and accomplishments make strides – or even become new realities for patients – we know our work, our manufacturing expertise, and our partnership helped make it happen.

We aren't simply a workplace. FUJIFILM Biotechnologies a community and place of passion – a place of what we call Genki. A place where diverse perspectives and people come to life. Where opportunity for growth has no end. Where passion is followed, discovered, and nurtured. Where the energy is undeniable, enthusiasm is pervasive, and drive is infectious. All of our global locations burst with curiosity, inspiration, and extraordinary purpose.

So as we continue to grow our teams, our global locations, and our capabilities, Genki will always be our cultural tie. That’s why we’re always looking for passionate, mission-driven people who want to commit their life’s work to enabling better outcomes for patients and their families.

For a full listing of jobs that will propel, inspire, and fulfill you, please visit: https://fujifilmbiotechnologies.fujifilm.com/careers/

We created this space on LinkedIn to give people a window into our work and culture. We’re highlighting employees’ passion, current openings, and why it’s never been a more exciting time to join!

Industry
Biotech & Life Sciences
Company Size
5,001-10,000 employees
Headquarters
Morrisville, North Carolina
Year Founded
Unknown
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