Director, Clinical Quality Evaluation And Inspection Intelligence

alvotech.is

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Gcp quality oversight architecture
Gcp audit program execution
Gcp inspection preparedness
** Alvotech is seeking a Director of Clinical Quality Evaluation and Inspection Intelligence to enhance the quality assurance processes within its integrated Clinical and Medical Research department. The ideal candidate should have extensive experience in GCP operations and audits, particularly in biopharmaceutical settings, and strong leadership skills to guide quality initiatives in clinical trials. **

Job Summary

  • The incumbent will be responsible for deploying risk-proportionate quality assurance and oversight tactics on assigned clinical programs/trials.
  • Lead modernisation and data analytics initiatives in CMQ, to deploy solutions enabling quality innovation.
  • Define and own inspectional intelligence framework for clinical study activities, encompassing signal detection, trend analytics, and insight-to-action workflows.

Matching Summary

Match Score: 75

** Alvotech is seeking a Director of Clinical Quality Evaluation and Inspection Intelligence to enhance the quality assurance processes within its integrated Clinical and Medical Research department. The ideal candidate should have extensive experience in GCP operations and audits, particularly in biopharmaceutical settings, and strong leadership skills to guide quality initiatives in clinical trials. **

Skills & Requirements

Must-have

  • GCP quality oversight architecture
  • GCP audit program execution
  • GCP inspection preparedness
  • Risk-proportionate quality assurance
  • Clinical trial quality integration
  • Data analytics for quality innovation

Nice-to-have

  • Team leadership experience
  • Cross-functional collaboration
  • Continuous improvement mindset
  • Regulatory procedure understanding

Key Requirements

  • MSc or PhD in life sciences
  • GCP Auditor qualification
  • 10+ years GCP operational/audit experience
  • 5+ years FDA/EMA/PMDA inspection exposure
  • 5+ years GCP audit experience
  • High digital acumen
  • Experience leading decentralized teams

Work Rights

Not specified

Tailored Resume

Cover Letter