Vice President, Quality

Position Summary

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. Reporting to the Chief Operating Officer, this leader will define the global quality vision and build the systems, culture, and capabilities required to advance REM-422 from clinical development through potential commercialization.

Key Responsibilities

• 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
  • Design, develop, and oversee a risk-based, phase-appropriate Quality Management System (QMS) spanning pre-clinical through commercialization
  • Ensure the QMS meets FDA, EMA, and ICH standards while remaining agile and fit-for-purpose for a clinical-stage organization
  • 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
• GxP Compliance & Health Authority Engagement
  • Lead Health Authority inspections (FDA, EMA, and other applicable agencies) and all inspection readiness activities across GxP disciplines
  • Serve as primary quality point of contact in regulatory interactions and submissions; ensure quality sections of INDs, NDAs/BLAs, MAAs, and other submissions meet agency expectations
  • Maintain a comprehensive inspection readiness program ensuring the organization is always in a state of audit readiness
  • Monitor evolving regulatory requirements, ICH guidance, and industry best practices; assess impact and implement appropriate updates to the QMS
• GCP & Clinical Quality
  • Provide GCP quality oversight across all clinical development programs, including protocol development, site qualification, monitoring, and data integrity
  • Partner with Drug Safety/Pharmacovigilance to provide quality oversight of PV activities, including SAE reconciliation, SUSAR reporting, PBRER/DSUR quality review, and inspection readiness for safety databases and processes
  • Ensure pharmacovigilance quality agreements and audit programs are in place with CROs and technology vendors supporting safety data collection and reporting
  • Collaborate closely with Clinical Operations, Biostatistics, and Regulatory Affairs to ensure clinical data quality standards are embedded throughout trial execution
• GMP & CMC Quality
  • Oversee quality aspects of small molecule drug substance and drug product manufacturing, including batch review and product release at Contract Manufacturing Organizations (CMOs)
  • Establish and maintain robust supplier qualification, oversight, and performance management programs for CMOs and Contract Research Organizations (CROs)
  • Lead GMP vendor qualification audits and for-cause audits; maintain a risk-stratified audit schedule
  • Partner with CMC, Regulatory, and Supply Chain to ensure product quality across the supply chain from development through commercial launch
• Quality Systems & Training
  • Own and continuously improve core QMS elements: document management, change control, deviation and CAPA management, risk management, and quality metrics
  • Design and implement a robust GxP training program; ensure training compliance is maintained across all relevant functions and third-party partners
  • Leverage quality metrics and KPIs to provide executive leadership with meaningful data-driven insights on quality performance and risk

Qualifications

• Education
  • Masters degree or higher in Biology, Chemistry, Pharmaceutical Sciences, Engineering, or a related scientific discipline
• Experience
  • 15+ years of progressive pharmaceutical/biotech industry experience, with 10+ years in quality management and leadership roles of increasing scope
  • Proven track record building, leading, and scaling quality organizations at clinical-stage and/or commercial-stage companies
  • Deep expertise in GCP and GMP compliance
  • Demonstrated success leading or hosting FDA and/or EMA GxP inspections; direct experience managing inspection responses and regulatory action items
  • Expert knowledge of FDA, EMA, and ICH guidelines and regulations applicable across the drug development lifecycle
  • Experience providing quality oversight of small molecule CMOs and clinical CROs in a virtual or hybrid operating model
• Skills
  • Exceptional leadership presence, integrity, and judgment; thrives in a dynamic, fast-paced environment where agility and accountability coexist
  • Familiarity with oncology drug development and oncology-specific clinical quality considerations
  • Working knowledge of EU GMP requirements and experience with dual US/EU regulatory programs

Salary Range

$293,000 - $358,000 USD

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