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Full-Time

Associate Director

Quality Systems

Confirmed live in the last 24 hours

Verve Therapeutics

Verve Therapeutics

201-500 employees

Developing gene editing therapies for heart disease

Biotechnology
Healthcare

Expert

Boston, MA, USA

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Communications
Management
Quality Assurance (QA)
Requirements
  • BA/BS in scientific discipline with an advanced degree preferred.
  • 9+ years demonstrated GMP quality experience in the pharmaceutical/ biopharmaceutical industry.
  • Experienced with QMS development for clinical stage biologics.
  • People management experience preferred.
  • 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.
Responsibilities
  • Develop and implement phase-appropriate Veeva based Quality Management System, to maintain compliance with FDA, ICH, EU, and other country-specific regulations.
  • Responsible for Veeva modules for QMS, Document Management, Training Management including set up, administration, maintenance, enhancement and improvements to the “out of the box” configuration under change control with computer system validation as appropriate.
  • Collaborate with other Verve departments to establish, review, revise and implement phase-appropriate quality-related systems and standards including GxP practices including SOPs, Lab Instructions and other quality documentation, as appropriate.
  • Implement, manage, and maintain GxP training.
  • Support CMC documentation and records management by ensuring a framework for all required documents are accurately and properly completed, including all batch disposition documents including related deviations, stability data, protocols, reports, etc. are uploaded into the cloud-based Quality system.
  • Implement Quality Management Review process and work with Quality Operations to maintain KPIs for product and process quality as well as QMS elements pertaining to training, periodic review, investigations, change controls, deviations and CAPAs.
  • Maintain audit readiness for responsible area and assist other groups with audit preparation and execution.
  • Implement and manage Quality Risk Management program with Technical Operations management.
  • Manage budget and resources to address needs of QA, including hiring decisions, talent management, and mentoring/development of QA team members.
  • Identify and address gaps or areas for improvement in systems, procedures, and quality initiatives.
  • Other responsibilities as assigned.

Verve Therapeutics is developing single-course gene editing medicines to address cardiovascular disease, with a focus on precision genetic editing technologies to lower LDL cholesterol and triglyceride levels. Their lead program, VERVE-101, targets heterozygous familial hypercholesterolemia, a potentially fatal genetic heart disease.

Company Stage

IPO

Total Funding

$419.3M

Headquarters

Cambridge, Massachusetts

Founded

2018

Growth & Insights
Headcount

6 month growth

5%

1 year growth

5%

2 year growth

40%
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Simplify's Take

What believers are saying

  • Significant financial backing, including a $63 million Series A2 financing and $60 million from Eli Lilly, positions Verve for robust R&D and clinical trial activities.
  • The potential for a 'one-and-done' treatment for cardiovascular diseases could revolutionize the field and offer a high-impact, life-saving solution.
  • Early-stage success and strategic partnerships could lead to lucrative licensing deals and further investment opportunities.

What critics are saying

  • The clinical-stage nature of Verve's therapies means they are still years away from potential market approval, posing a long-term risk.
  • The recent stock price drop following a public offering indicates market volatility and potential investor uncertainty.

What makes Verve Therapeutics unique

  • Verve Therapeutics focuses on gene-editing therapies specifically for cardiovascular diseases, setting it apart from other CRISPR-based companies that target a broader range of conditions.
  • Their 'one-and-done' gene-editing approach aims to provide a single, curative treatment, which is a significant advantage over traditional, ongoing therapies.
  • Partnerships with major pharmaceutical companies like Eli Lilly enhance their credibility and provide substantial financial and research support.