Senior Specialist, Quality System, Qa

Trzdev36

**
Global alignment & harmonization
Ecms implementation
Clinical lifecycle readiness
** Trzdev36 is seeking a Senior Specialist in Quality Systems to lead and harmonize quality processes, ensure compliance with GMP standards, and manage training and document control. The ideal candidate will have over five years of experience in a GMP environment, with a focus on quality systems, and possess strong technical knowledge in regulations and standards. **

Job Summary

  • Lead gap assessments and remediation to ensure full integration and consistency across global standards, templates, and metrics.
  • Ensure controls support tech transfer from development to GMP clinical supply, scale-out/scale-up, protocol amendments, and eventual commercial transition.
  • Actively monitor and review Key Performance Indicators related at site/ function and escalate trends and signals to line manager, provide routine reports to site leadership and global quality.

Matching Summary

Match Score: 75

** Trzdev36 is seeking a Senior Specialist in Quality Systems to lead and harmonize quality processes, ensure compliance with GMP standards, and manage training and document control. The ideal candidate will have over five years of experience in a GMP environment, with a focus on quality systems, and possess strong technical knowledge in regulations and standards. **

Skills & Requirements

Must-have

  • Global Alignment & Harmonization
  • ECMS implementation
  • Clinical Lifecycle Readiness
  • Document Control
  • Data Integrity
  • GMP training matrices

Nice-to-have

  • Strong ownership and self-motivation
  • Cross-functional collaboration and prioritization
  • Drives continuous improvement
  • Rigorous logical thinking

Key Requirements

  • 5+ years of experience in robust GMP quality system
  • 2+ years focused on Quality system
  • Bachelor’s degree in pharmacy, Life Sciences, Biotechnology
  • Excellent English (spoken and written)

Work Rights

Not specified

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