Full-Time

Associate Director

Quality Assurance, Gcp

Posted on 5/22/2024

Relay Therapeutics

Relay Therapeutics

201-500 employees

Precision medicines company targeting genetic diseases

AI & Machine Learning
Data & Analytics

Senior

Cambridge, MA, USA

Required Skills
Google Cloud Platform
Requirements
  • Bachelor’s degree in a scientific field
  • Minimum of 10+ years of Quality Assurance/GCP/GCLP/GVP Operations experience in pharmaceutical or biotech industry
  • In-depth knowledge of GCP/GCLP/GVP and QA principles, practices, and standards; thorough understanding of FDA, MHRA, EMA and ICH quality regulations
Responsibilities
  • Serve as primary Quality contact for external clinical and patient safety vendors
  • Contribute to the development of Quality Management Systems
  • Review and approve GCP/GCLP/GVP documents
  • Create and execute risk-based clinical trial audit plans
  • Develop and implement inspection readiness strategy
  • Conduct internal audits and provide audit metrics
  • Develop and execute Quality Agreements with vendors
  • Interpret and manage quality investigations
  • Communicate with vendors to address activities
  • Contribute to the development of the Quality Management System
  • Provide Quality Assurance expertise and guidance to external CROs
  • Review GCP/GCLP/GVP documentation and regulatory submissions
  • Contribute to other areas of Quality Assurance as needed

Relay Therapeutics is dedicated to advancing the field of precision medicine by employing its innovative Dynamo TM Platform to visualize protein motion through high-definition movies. This cutting-edge approach enhances its ability to drug targets more effectively, especially in critical areas like precision oncology and genetic diseases. The company's commitment to leveraging advanced experimental and computational methodologies in structural biology, biophysics, chemistry, and biology positions it as a leader in developing targeted therapies that address complex diseases. Working at Relay Therapeutics offers a unique opportunity to contribute to transformative healthcare solutions and operate at the forefront of biotechnological research.

Company Stage

IPO

Total Funding

$1.2B

Headquarters

Cambridge, Massachusetts

Founded

2016

Growth & Insights
Headcount

6 month growth

-5%

1 year growth

-6%

2 year growth

7%

Benefits

Medical, dental, vision

Life, disability, & FSA

401k

Commuter benefits

Parental leave

Home office stipend

Tuition reimbursement

PTO