Senior Director - GLP, Biomarkers and Research Quality
Vertex Pharmaceuticals · Boston, MA
QualityFull-time$215k–$322kCompany career page
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Role summary
Senior Director role overseeing quality assurance strategy for research, GLP studies, biomarker development, and diagnostics at a global biotechnology company. Reports to functional leaders and manages an operational quality team responsible for compliance, data integrity, and regulatory alignment across clinical evidence generation and product vigilance.
What they're looking for
- Master's degree in scientific or allied health field with 10+ years relevant experience, or Bachelor's degree with 15+ years
- Strategic leadership experience in quality assurance and regulatory compliance
- Deep knowledge of GLP, research quality, biomarker development, and IVD processes
- Understanding of regulatory requirements across local, regional, and international standards
- Experience managing operational quality teams and cross-functional governance
- Proven ability to identify, remediate, and escalate quality and compliance issues
What you'll be doing
- Define and oversee quality assurance strategy for research, GLP studies, biomarker development, and vendor oversight
- Lead operational quality team to anticipate compliance issues and implement improvement methods
- Identify, remediate, and escalate quality issues across research, GLP, biomarker, and IVD activities
- Provide periodic updates on process health and communicate trending insights to business and quality leaders
- Chair operational governance meetings and oversee inspection readiness activities
Privacy & handoff
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