3 дня назад
Senior Director - GLP, Biomarkers and Research Quality (Biotechnology)
215 000 - 322 400$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Director - GLP, Biomarkers and Research Quality (Biotechnology): Leading end-to-end quality assurance strategy for research, GLP studies, biomarker development, diagnostics, and vendor activities with an accent on regulatory compliance, data integrity, and risk-informed oversight. Focus on overseeing remediation and inspection readiness, guiding cross-functional quality initiatives, and leading operational quality teams across research and pre-clinical programs.
Location: Boston, MA, United States; hybrid-eligible or on-site eligible. Hybrid work allows remote work up to two days per week, while the on-site option requires five days per week on-site.
Salary: $215,000–$322,400 base salary annually, plus eligibility for an annual bonus and annual equity awards.
Company
Vertex is a global biotechnology company focused on scientific innovation and patient outcomes.
What you will do
- Lead the end-to-end quality assurance strategy for research, GLP, biomarker development, diagnostics, and product vigilance activities.
- Partner with functional leaders to ensure quality and compliance oversight of processes, systems, programs, and associated data.
- Oversee research, assay development, GLP animal studies, in vitro diagnostic development, and R&D vendor quality activities.
- Lead an operational quality team in identifying compliance risks, resolving quality issues, and implementing pragmatic improvements.
- Oversee inspection readiness, quality trending, governance meetings, and communication of quality insights to business and quality leaders.
- Provide strategic direction, coaching, and mentoring to direct reports while guiding cross-functional initiatives and regulatory implementation.
Requirements
- M.S. or equivalent degree with 10+ years of relevant experience, or B.S. in a scientific or allied health field with 15+ years of relevant experience, or a comparable background.
- Experience with research quality, GLP, biomarker development, in vitro diagnostics, regulatory compliance, and data integrity.
- Experience leading quality teams and overseeing remediation, escalation, inspection readiness, and vendor governance.
- Ability to provide strategic direction across Research, Biomarker Development, Diagnostics, and Quality Assurance functions.
- Ability to work in Boston, MA under the hybrid or on-site Flex designation.
Culture & Benefits
- Hybrid work of up to two remote days per week or a five-day on-site schedule with ad hoc flexibility.
- Medical, dental, and vision benefits.
- Generous paid time off, including summer and winter company shutdowns.
- Educational assistance programs, including student loan repayment.
- Commuting subsidy, matching charitable donations, 401(k), annual bonus, and equity award eligibility.
- Continuous learning opportunities related to AI, technology, automation, and industry trends.
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