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Senior Quality Assurance Manager
2 months ago
Position Overview:
We are in search of a Quality Assurance leader to play a pivotal role in the development of our Quality function at Relay Therapeutics. This position involves collaboration with Clinical Development teams to manage various external contract partners while actively shaping the Quality Management System as our operations expand. This multifaceted role offers an exciting opportunity for individuals who thrive in dynamic environments. At Relay Therapeutics, we prioritize Quality while fostering a light-hearted and collaborative atmosphere, ensuring that each day presents new challenges and opportunities for growth.
Key Responsibilities:
- Act as the primary Quality liaison for external clinical and patient safety partners.
- Contribute to the establishment of GCP/GCLP/GVP Quality Management Systems, perform risk assessments, and identify areas for auditing and process enhancement.
- Review and approve all documentation related to GCP/GCLP/GVP, including study protocols, clinical study reports, investigator brochures, informed consent forms, safety management plans, and aggregate reports.
- Develop and implement risk-based clinical trial audit strategies and participate in the evaluation and qualification of clinical vendors.
- Collaborate with Clinical Development teams to create and execute a GCP/GCLP/GVP inspection readiness strategy.
- Conduct internal audits, providing metrics and observations, and develop comprehensive CAPAs for cross-functional team and management review.
- Formulate and execute Quality Agreements with relevant vendors.
- Oversee and interpret quality investigations related to GCP/GCLP/GVP operations.
- Maintain proactive communication with GCP/GCLP/GVP vendors to address and resolve complex issues while fostering positive relationships and continuous improvement.
- Exhibit flexibility and adaptability, contributing to the Quality Management System's development beyond GCP/GCLP/GVP, including monitoring performance metrics.
- Provide Quality Assurance expertise, leadership, and guidance to external CROs and support Relay's Clinical Development teams.
- Review applicable GCP/GCLP/GVP documentation and regulatory submissions.
- Contribute to various aspects of Quality Assurance as Relay's Quality team continues to grow and evolve.
Qualifications for Success:
- Strong attention to detail while maintaining a focus on overarching goals of continuous improvement.
- A collaborative team player who thrives in a fast-paced environment, with a customer service-oriented mindset.
- Willingness to engage in all facets of the role, regardless of size or complexity.
- Excellent communication skills, with a readiness to represent Relay Therapeutics at GCP/GCLP/GVP sites, both domestically and internationally.
Educational Background:
- Bachelor's degree in a scientific discipline.
- At least 10 years of experience in Quality Assurance/GCP/GCLP/GVP Operations within the pharmaceutical or biotech sectors.
- Comprehensive understanding of GCP/GCLP/GVP and QA principles, practices, and standards, along with familiarity with FDA, MHRA, EMA, and ICH quality regulations.
About Relay Therapeutics:
Relay Therapeutics is a clinical-stage precision medicines company dedicated to transforming the drug discovery process to deliver life-changing therapies to patients. Our innovative approach leverages insights into protein motion to effectively target previously challenging protein targets, focusing initially on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform combines cutting-edge experimental and computational techniques to provide a unique understanding of protein structure and dynamics. We have assembled a world-class team of experts across various disciplines, driven by a commitment to collaboration at every stage of our drug discovery journey.
