Associate Director, Gxp Quality, Compliance And Audit - Evinova

Evinova

United States
Hybrid
Gxp quality management system
Gcp expertise software lifecycle
Internal audit execution and reporting
The GxP Quality, Compliance and Audit Associate Director will join a rapidly growing team at Evinova, offering a rare opportunity to shape and build the future of quality and compliance within a scaling health-tech business

Job Summary

  • The GxP Quality, Compliance and Audit Associate Director will join a rapidly growing team at Evinova, offering a rare opportunity to shape and build the future of quality and compliance within a scaling health-tech business.
  • This role will be instrumental in ensuring our clinical trial solutions meet global regulatory standards, including ICH, EMA, FDA, and other applicable guidelines.
  • At Evinova, we are driven by a shared purpose to transform health through data and digital innovation.

Matching Summary

The GxP Quality, Compliance and Audit Associate Director will join a rapidly growing team at Evinova, offering a rare opportunity to shape and build the future of quality and compliance within a scaling health-tech business.

Skills & Requirements

Must-have

  • GxP Quality Management System
  • GCP expertise software lifecycle
  • Internal audit execution and reporting
  • Supplier and third-party qualification
  • Quality Issue Management process
  • Regulatory inspection management

Nice-to-have

  • Drive innovation in Quality
  • Strong influencing and negotiation
  • Lead change and navigate complexity
  • Develop and mentor talent
  • Pragmatic decision-maker
  • Resilient and proactive

Key Requirements

  • Bachelor's degree in Life Sciences or related field
  • 5+ years in pharmaceutical, biotech, or medical device
  • Strong knowledge of global GxP and GCP
  • Experience developing Quality Management Systems
  • Experience supporting Health Authority inspections
  • Proven experience managing GxP compliance activities
  • Hands-on experience conducting GxP audits

Work Rights

Not specified

Tailored Resume

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