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 

Estimated Salary Range: [$68,000 - $97,000].

The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills and location.

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