Specialist, Quality Assurance (GCP)

The Opportunity

We are seeking a Quality professional to join our GCP Quality Assurance function at Relay Therapeutics (Relay Tx). Under the direction of the Senior Director, you will partner with your QA, QMS, and Clinical Development colleagues in supporting our clinical trial quality and strengthening of our clinical QMS as our pipeline evolves. At Relay Tx, we take Quality seriously, but we don’t take ourselves too seriously. You’ll have fun in our collaborative and energetic environment where you’ll face new challenges every day. 

Your Role

• You will track and follow up on GCP/GCLP/GVP quality issues/events and CAPAs (internal and CRO) in Veeva to ensure timely closure and documentation 
• You will support audit execution for investigator sites, clinical vendors, and internal processes, including working with SMEs to gather required documents, ensuring audit related timelines are met, and audit certificates are properly filed in the TMF 
• You will assist CQA and clients in Precision Medicine with procedural document (e.g., SOPs) development and management. 
• You will partner with the assigned CQA Lead to complete quarterly QA TMF reviews 
• You will assist with QA review of GCP documents, including SOPs, protocols, and other study materials, as requested 
• You will support inspection readiness and inspection management at the direction of the CQA Lead 
• You will support CQA training initiatives, communication, and reporting efforts 
• There is the potential to partner with an existing CQA Lead on assigned studies to build working knowledge of GCP activities 

Competencies For Success:

• You have a keen attention to detail, strong organizational skills, and a reputation for follow-through. 
• You are a team player, flexible, and easy to work with in a fast and collaborative environment. You are solution oriented with a customer service approach. 
• You have the ability to manage multiple priorities and proactively communicate status updates. 

Your Background:

• Bachelor’s degree in a scientific field preferred 
• 2-5 years of Quality Assurance/GCP/GCLP/GVP Operations experience in pharmaceutical or biotech industry 
• Hands on experience with Veeva systems preferred 
• Familiarity with GCP principles and clinical trial processes 
• Competence in MS Office, especially the ability to develop polished PowerPoint presentations 

#Jo1

About Relay Therapeutics

Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process.  

Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you’re excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!