Senior Director, Quality Assurance Compliance

August 18

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IDEAYA Biosciences

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Synthetic lethality precision medicine oncology company pursuing– an emerging class of precision medicine targets.

Synthetic Lethality and Precision Medicine

51 - 200

💰 $80M Post-IPO Equity on 2022-09

Description

• Provides leadership, direction, and oversight of Quality Compliance activities, including risk management & escalation, regulatory inspection / partner audit management, internal & external audit program, quality vendor management, quality metrics, management review, and annual compliance training. • Works directly with Quality colleagues to identify, prioritize and execute quality improvement efforts to continually improve efficiency, effectiveness, and compliance with applicable regulations. • Work closely with Project Teams to ensure adherence to the Quality Management System, SOPs, and regulations/guidelines. • Develop, implement and manage inspection readiness activities to support regulatory inspections and partner audits. • Provide strategic direction and leadership of the Vendor Qualification program including external auditing. • Develops and manages Quality Council and Quality Management Review programs including the development of quality metrics. • Identifies and implements compliance training for company staff supporting GxP activities and processes. • Improves, implements, and manages effective risk escalation processes. • Support the development of the company’s Quality strategy and policies. • Communicates with and influences internal and external customers across the company to ensure compliant and aligned resolution of project related issues and investigations. • Develop presentation materials and present to senior management. • Support Business Development and Due Diligence efforts. • Other related duties as assigned.

Requirements

• Bachelor of Arts/Bachelor of Science in a related discipline. • 12+ years of experience in quality assurance supporting GxP operations. • Demonstrated experience in defining, developing and implementing Quality compliance processes supporting Late-Stage Clinical Development and Commercial activities. • Strong Leadership Skills including strong teamwork, collaboration, transparent communication, integrity, change agent, developing people, leading by example. • Experience with FDA/Health Authority inspection readiness and successful inspections, conducting QA audits, and working with pharmaceutical processes are required. • Previous experience conducting compliance auditing of clinical sites, CROs, CMOs, laboratories and/or vendors, and detailed knowledge of regulated documentation systems is highly desirable. • A strong working knowledge of cGMP, GCP, GLP, GvP, ICH guidelines, general compliance regulations and their application is necessary. • Must be able to travel without any legal restrictions across international borders.