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Primary Responsibilities:
- Develop and report key quality metrics across all clinical programs and trials
- Assess current-state quality across programs, processes, and trials
- Identify trends, risks, and lead process and system improvements
Vendor Quality Oversight:
- Partner with vendor management to update Quality Agreement templates
- Develop a program and processes for quality oversight and accountability of CROs and other vendors
- Develop and report quality metrics for CROs and critical clinical vendor
Quality Events, Audits & Inspections:
- Review and approve deviations, investigations, and CAPAs
- Lead or participate in audits and regulatory inspections
- Drive inspection readiness at local and global levels
Praxis Precision Medicines
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Their core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of their business.