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Neurocrine Biosciences logo

Director, Clinical Quality Assurance

Neurocrine Biosciences · CH Allschwil

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Clinical OperationsFull-timeCompany career page

The apply link worked recently (not employer-confirmed).

What they're looking for

  • RN, BSN, BS/MS, or BA in scientific or healthcare field plus 12+ years industry experience
  • Masters degree in related field plus 10+ years industry experience (alternative pathway)
  • Extensive GCP audits, inspections, and related compliance experience
  • Demonstrated experience developing and implementing GCP QA systems and procedures
  • Previous managerial experience leading quality teams
  • Advanced knowledge of GCP regulations and regulatory inspection processes
  • Strong communication skills for interactions with regulatory authorities and stakeholders

What you'll be doing

  • Develop clinical QA strategy and establish stakeholder relationships to achieve GCP compliance
  • Build and lead quality management team to implement systems and ensure study compliance
  • Lead preparations for regulatory inspections including mock inspections and readiness planning
  • Conduct investigator site and vendor audits to assess data integrity and GCP adherence
  • Partner with clinical development and regulatory affairs on compliance issues and quality guidance

Privacy & handoff

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RoleLantern checked active
RoleLantern checkedNeeds clarity
Date posted4 days ago
Last source check1 day ago
Salary listedNeeds clarity
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