Associate Director – Quality Assurance

Associate Director – Quality Assurance

Requirements

• Bachelor’s degree in a scientific field.
• Minimum of 8 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.

Responsibilities

• Be the GCP Quality Lead to assigned studies/programs.
• Review all things GCP/GCLP/GVP; study protocols and manuals, clinical study reports, investigator brochures, informed consent forms, safety management plans, aggregate reports, etc.
• Create and execute risk-based clinical trial audit plans and participate in clinical vendor evaluation and qualification.
• Create and implement a GCP/GCLP/GVP inspection readiness strategy and plan in collaboration with Clinical Development colleagues.
• Conduct/support internal audits and provide audit metrics, audit observations, and develop robust CAPAs for cross functional team and management review.
• Develop and execute Quality Agreements with applicable vendors.
• Interpret and manage quality investigations associated with GCP/GCLP/GVP operations.
• Effectively communicate with GCP/GCLP/GVP vendors to address and resolve complex and routine activities while building positive client/vendor relationships.
• Contribute to the continued development of the GCP/GCLP/GVP Quality Management Systems, conduct risk assessments and identify areas to be audited and potential process improvements.
• Provide Quality Assurance subject matter expertise, leadership, and guidance to external CROs as well as in support of Relay Clinical Development colleagues.
• Provide review of applicable GCP/GCLP/GVP documentation and regulatory submissions.
• Contribute significantly to other areas of Quality Assurance as needed as Relay’s Quality team grows and the QMS evolves.
• Help the study teams ensure that they are inspection ready at all times and be well prepared for any future site or sponsor inspections across the globe.

Preferred Qualifications

• Keen attention to detail but can stay focused on the big picture of continual improvement.
• Team-player, flexible and easy to work with in a fast and collaborative environment.
• Solution oriented with a customer service approach.
• Willing to “roll up your sleeves” and engage in all aspects of the role, big and small.
• Great communication skills and willingness to travel to GCP/GCLP/GVP sites, domestic and international.