What are the responsibilities and job description for the Director, Quality Assurance (GCP) position at Relay Therapeutics?
The Opportunity
We are seeking a Director level Quality professional with expertise in GCP / GVP / GLP regulations to continue to expand the breadth of oversight within a growing and evolving Quality function at Relay Tx. You will partner with your clinical and nonclinical development colleagues to oversee a network of contract vendors while simultaneously building GCP / GVP / GLP processes and standards to support our pipeline and future growth. This is an opportunity to build a small team and define the standards to install the procedural guardrails to ensure our consistent delivery of high quality GCP / GVP / GLP deliverable at Relay Tx and our network of vendors. 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
- Provide expertise in GCP, GVP and GLP compliance interpretation, consultation, training, and recommendations to clinical and nonclinical development functions and program teams.
- Develop standards and practices to support clinical and nonclinical project teams and oversee a network of vendors providing regulated services.
- You will ensure that clinical and nonclinical programs have adequate Quality support and work with Head of QA to ensure adequate planning and budgeting.
- You will conduct risk assessments and identify areas and vendors to be audited and identify process improvements for all work at Relay Tx involving GCP / GVP / GLP.
- You will plan / conduct / oversee GCP / GVP / GLP internal audits and provide audit metrics, audit observations, and develop robust CAPAs for cross functional team and management review.
- You will provide GCP / GVP / GLP subject matter expertise related to inspection readiness preparation and provide SME support during inspections. Facilitate appropriate and timely inspection responses and follow-up actions.
- You will lead, interpret and manage quality investigations associated with GCP / GVP / GLP operations.
- You will be flexible and adaptable. You will collaborate with your Quality Management Systems colleagues and ensure Relay Tx systems work fluidly to ensure GXP compliance.
- You will define, analyze, report, and present metrics to functional teams and Quality management; recommend any required actions and monitor implementation.
- You will provide review of applicable GCP / GCLP / GVP documentation and regulatory submissions.
Competencies for Success
Your Background
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!
