Full-Time

Associate Director

Quality Systems

Posted on 8/13/2024

Verve Therapeutics

Verve Therapeutics

201-500 employees

Develops gene editing therapies for cardiovascular disease

Biotechnology
Healthcare

Senior, Expert

No H1B Sponsorship

Boston, MA, USA

Hybrid role requiring 3 days in the Boston office.

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
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 focuses on developing gene editing therapies to treat cardiovascular disease. Their approach involves creating single-course treatments that aim to provide lasting solutions, unlike traditional therapies that require ongoing management. The company specifically targets the PCSK9 and ANGPTL3 genes, which are known to help lower blood lipid levels. This focus on gene editing sets Verve apart from competitors who may rely on more conventional treatment methods. The goal of Verve Therapeutics is to offer potentially curative options for patients with cardiovascular diseases, improving their long-term health outcomes.

Company Stage

IPO

Total Funding

$353.6M

Headquarters

Cambridge, Massachusetts

Founded

2018

Growth & Insights
Headcount

6 month growth

1%

1 year growth

0%

2 year growth

4%
Simplify Jobs

Simplify's Take

What believers are saying

  • Eli Lilly's $60M investment shows confidence in Verve's cardiovascular gene editing approach.
  • CRISPR therapy approvals, like Casgevy, pave the way for Verve's regulatory success.
  • CRISPR's success in genetic blindness supports Verve's potential in cardiovascular treatments.

What critics are saying

  • Rapid CRISPR advancements may increase competition, affecting Verve's market share.
  • Most CRISPR therapies are in early stages, delaying Verve's market entry and revenue.
  • Verve's stock drop post-offering suggests investor concerns about financial stability.

What makes Verve Therapeutics unique

  • Verve focuses on single-course gene editing for cardiovascular diseases, unlike chronic treatments.
  • The company targets PCSK9 and ANGPTL3 genes, crucial for lowering blood lipid levels.
  • Verve's approach offers potentially curative treatments, setting it apart in the biotech sector.

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Benefits

Hybrid Work Options

INACTIVE