Executive Director
Quality Assurance
Confirmed live in the last 24 hours
Verve Therapeutics

201-500 employees

Develops gene editing therapies for heart disease
Company Overview
Verve Therapeutics, a clinical-stage biotechnology company, is a leading player in the fight against heart disease, leveraging its expertise in cardiovascular medicine, human genetics, and gene editing to develop transformative, once-and-done therapies. The company's unique approach to gene editing, designed to permanently lower LDL cholesterol and triglyceride levels, sets it apart from competitors and positions it at the forefront of precision genetic medicine. With a culture that fosters passion and drive, Verve has been recognized as a "Best Places to Work" by the Boston Globe, demonstrating its commitment to both its mission and its employees.

Company Stage


Total Funding





Boston, Massachusetts

Growth & Insights

6 month growth


1 year growth


2 year growth

Cambridge, MA, USA
Experience Level
Desired Skills
Quality Assurance (QA)
QA & Testing
  • BA/BS in scientific discipline with an advanced degree preferred
  • 15+ years demonstrated GMP quality experience in the pharmaceutical/ biopharmaceutical industry
  • Experienced with drug development for complex biologics
  • Experience interacting with CDMOs, QPs, and relevant regulatory authorities
  • Experience with review of regulatory requirements and filings
  • Strong interpersonal and communication skills (written and verbal), team player, with good decision-making ability that is results oriented without compromising quality
  • Demonstrated project management and organizational skills
  • Strong aptitude with Microsoft Office applications (Word,Excel, etc.)
  • Ability to travel, as needed
  • Provide leadership and oversight for GxP QA including:
  • Development and implementation of a phase-appropriate Quality Management System, including SOPs, change control, investigations, CAPA, compliance, document management, training management and validation
  • Quality Operations function responsible for disposition of GMP materials and products based on review of batch records, test records, regulatory filings, GMP requirements and other Verve requirements
  • Vendor qualifications and external/internal audits and regulatory inspections
  • QA support for Verve GxP QC laboratory operations
  • Manage budget and resources to address strategic needs of QA, including hiring decisions, talent management, and mentoring/development of QA team members
  • Establish and implement SOPs and phase-appropriate quality-related systems and standards to maintain compliance with FDA, ICH, EU, and other country-specific regulations including GxP practices
  • Identify and address gaps or areas for improvement in systems, procedures, and quality initiatives
  • Collaborate with Verve Manufacturing, QC and Process Development and R&D on issues such as review and approval of batch records, certificates of analysis/testing and compliance, in-process and release test methods, specifications, stability protocols/reports, analytical method validations, technical study reports, trending reports, etc
  • Support review of regulatory filing activities, as needed
  • Establish and maintain Quality Technical Agreements with CDMOs and CTLs
  • Represent Quality at internal and external project team meetings and build relationships with Quality counterparts at CDMOs and CTLs
  • Maintain a Quality Risk Management system to identify and mitigate compliance risks
  • Other responsibilities as assigned