Vertex Pharmaceuticals

Senior Manager, Biomarker Operational Quality

Vertex Pharmaceuticals

contract

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Origin:  • 🇺🇸 United States

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Salary

💰 $75 - $85 per hour

Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Provide biomarker quality leadership and oversight across GxP-related research, development, clinical trials, and potential commercialization into IVDs
  • Collaborate with business partners and GCP Operational Quality to drive quality outcomes and operational excellence
  • Support operational management oversight, audit strategy, regulatory document reviews (BBs, INDs, IDEs, TMFs)
  • Develop scope for GCLP and GCP biomarker vendor audits and participate in vendor quality engagement
  • Contribute to inspection readiness, design of quality metrics, governance meetings, and due diligence/integration activities

Requirements

  • Bachelors Degree in a scientific or allied health field
  • Typically requires 6 years experience or the equivalent combination of education and experience
  • Experience in a matrixed environment and in a larger organization; subject matter expert in diverse clinical labs
  • Companion diagnostic (CDx) GMP & QA experience
  • Broad knowledge of CLIA regulations (42 CFR Part 493) and international equivalents; ISO15189:2022, CLSI
  • Experience with GxP, GCP, GCLP, GLP and vendor audits
  • Demonstrated ability to collaborate effectively at all levels; excellent communication and influencing skills
  • Quality metrics, dashboards, analysis and improvement programs
  • Strong problem solving and critical thinking skills