Senior Quality Assurance Associate, Drug Substance

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.