Senior Quality Assurance Associate, Drug Substance

FUJIFILM Biotechnologies

Base: not specified; bonus/equity: bonus pyckage m...
Hybrid
Drug substance manufacturing under cgmp/gdp
Approve deviations capas change controls
Inspection and audit readiness
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

Job Summary

  • 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.
  • FUJIFILM Biotechnologies offers a competitive salary and bonus package, health insurance, massage and physiotherapy, health check, fitness center, hybrid working, and a supportive culture with traditions like bell ringing for milestones.
  • You will contribute across a 55+ person QA team with clear decision rights, open doors, and colleagues who back you, enabling growth, recognition, and visible impact.

Matching Summary

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.

Salary

Base: Not specified; Bonus/Equity: Bonus package mentioned; Benefits: Health insurance, massage, physiotherapy, health check, fitness center, hybrid working

Skills & Requirements

Must-have

  • drug substance manufacturing under cGMP/GDP
  • approve deviations CAPAs change controls
  • inspection and audit readiness
  • risk-based decision making
  • documentation and procedure management

Nice-to-have

  • collaboration and quick huddles
  • coaching mindset
  • open communication and shared learning
  • bias to action and crisp decisions
  • hybrid working environment

Key Requirements

  • 5+ years drug substance manufacturing experience
  • degree in Biotechnology Pharmacy Medicine Chemistry Biology or related
  • strong knowledge of GxP legislation
  • experience with deviations CAPAs change controls
  • experience in cGMP/GDP environments

Work Rights

Not specified

Tailored Resume

Cover Letter