Associate Director, Quality Assurance (gcp)

The Opportunity:

We are seeking a Quality professional to be a cornerstone to a growing and evolving Quality function at Relay Tx.  You will partner with your Clinical Development colleagues to oversee several external contract vendors while simultaneously contributing and influencing the build of the Quality Management System as the team evolves along with our pipeline. This is a “wear many hats” role and an exciting opportunity for someone who enjoys the build.  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 be front and center, serving as Relay Tx’s primary Quality contact for external clinical and patient safety vendors.
• You will contribute to the development of the GCP/GCLP/GVP Quality Management Systems, conduct risk assessments and identify areas to be audited and potential process improvements.
• You will review and approve all things GCP/GCLP/GVP; study protocols and manuals, clinical study reports, investigator brochures, informed consent forms, safety management plans, aggregate reports, etc.
• You will create and execute risk-based clinical trial audit plans and participate in clinical vendor evaluation and qualification.
• You will create and implement a GCP/GCLP/GVP inspection readiness strategy and plan in collaboration with your Clinical Development colleagues
• You will conduct internal audits and provide audit metrics, audit observations, and develop robust CAPAs for cross functional team and management review.
• You will develop and execute Quality Agreements with applicable vendors.
• You will interpret and manage quality investigations associated with GCP/GCLP/GVP operations.
• You will be proactive, and you will effectively communicate with GCP/GCLP/GVP vendors to address and resolve complex and routine activities while building positive client/vendor relationships, fostering continuous improvement, and adding value to the Clinical Development team.
• You will be flexible and adaptable.  You will eagerly contribute to the development of the Quality Management System even in aspects that extend beyond GCP/GCLP/GVP, including maintaining and reviewing metrics to monitor performance.
• You will provide Quality Assurance subject matter expertise, leadership, and guidance to external CROs as well as in support of your Relay Clinical Development colleagues.
• You will provide review of applicable GCP/GCLP/GVP documentation and regulatory submissions.
• You will contribute significantly to other areas of Quality Assurance as needed as Relay’s Quality team grows and the QMS evolves.

Competencies for Success: 

• You have a keen attention to detail but can stay focused on the big picture of continual improvement.
• 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 are willing to “roll up your sleeves” and engage in all aspects of the role, big and small.
• You have great communication skills and don’t mind showing them off by traveling to GCP/GCLP/GVP sites, domestic and international, and being the Quality ambassador of Relay Tx.  

Your Background: 

• 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. 

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