Full-Time

Senior Specialist/Manager

CMC Quality Assurance

Posted on 5/2/2024

Vor Bio

Vor Bio

51-200 employees

Developing cell therapies for blood cancers

Biotechnology

Senior

Cambridge, MA, USA

Requirements
  • BA/BS and a minimum of 6-10 years' experience in a Quality Assurance position within a GMP environment.
  • Strong knowledge of GMP regulations and quality systems
  • Ability to support a risk-based approach to Quality Management Systems
  • Experience with cell and gene therapy products is preferred
  • Experience with QC analytical methods is preferred
  • Must be able to work onsite at our Cambridge facility on a regular basis
Responsibilities
  • Responsible for reviewing and approving clinical manufacturing batch records, testing records, deviations, and other batch related records and performing disposition activities
  • Responsible for quality assurance oversight of testing and environmental monitoring activities
  • Responsible for reviewing and approving stability related activities
  • Review and approve shipping related activities as well as temperature excursions activities
  • Provide on-the-floor QA support for manufacturing activities as needed
  • Ensure documentation aligns with regulatory standards and Vor expectations
  • Review and approve SOPs and specifications as needed
  • Draft, review, approve quality assurance SOPs as needed

Vor Bio is dedicated to transforming the treatment of blood cancers through a combination of advanced Hematopoietic Stem Cell biology, genome engineering, and CAR-T cell technology. By focusing on making healthy cells resistant to targeted therapies, this company offers a unique workplace for those passionate about cutting-edge healthcare solutions. Its strong commitment to research and development in oncology positions it as a leader in the industry, providing employees with the opportunity to be at the forefront of medical science and contribute to significant advancements in patient care.

Company Stage

IPO

Total Funding

$267.8M

Headquarters

Cambridge, Massachusetts

Founded

2015

Growth & Insights
Headcount

6 month growth

4%

1 year growth

15%

2 year growth

34%