Remix Therapeutics
Vice President, Quality
Watertown, MA · Exec
Sponsorship not specifiedDetected 40 days ago
GCPSupply ChainPerformance ManagementGMPFDA RegulatoryPharmacovigilanceResearchLeadershipGxPBiostatisticsRegulatory Affairs
About the role
- Remix is seeking an exceptional Vice President of Quality to serve as the architect and guardian of our quality organization at a pivotal moment in our growth.
Responsibilities
- Design, develop, and oversee a risk-based, phase-appropriate Quality Management System (QMS) spanning pre-clinical through commercialization
- Build and lead Remix's quality organization from the ground up
- hire and develop a small, high-impact team while establishing the infrastructure, processes, and culture to scale alongside the pipeline
- Maintain a comprehensive inspection readiness program ensuring the organization is always in a state of audit readiness
- assess impact and implement appropriate updates to the QMS
Benefits
- The VP of Quality will bring deep expertise across GxP disciplines, a risk-based mindset, and the leadership presence to inspire confidence across internal teams, external partners, and Health Authorities alike.
- Quality Vision & Strategy
- Define and drive the Quality vision, objectives, and culture of Remix, establishing quality as a strategic enabler of the company's mission
- GxP Compliance & Health Authority Engagement
- Lead Health Authority inspections (FDA, EMA, and other applicable agencies) and all inspection readiness activities across GxP disciplines
Company info
- Remix Therapeutics is a clinical-stage biopharmaceutical company pioneering a new class of medicines that modulate RNA splicing to address the underlying biology of disease.
- Our lead program, REM-422, targets pre-mRNA splicing in oncology and represents a fundamentally differentiated approach to drug discovery.
- Headquartered in Watertown, MA, Remix is advancing its pipeline with the urgency and scientific rigor that patients deserve.
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