Senior Director - GLP, Biomarkers and Research Quality
$215k - $322.4kVertex Pharmaceuticals
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.
Responsibilities
- 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
Requirements
- 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
Compensation: $215,000 - $322,400 base
Vacancy posted 21 days ago
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