Director, Quality Systems & Compliance

Job description

JOB SUMMARY: This role leads Quality Systems and Compliance, with responsibility for designing and implementing a Quality Management System (QMS) that supports current clinical development programs and the organization’s growing pipeline. The role partners closely with Regulatory, Medical, Clinical, R&D, and Technology leadership to ensure quality systems enable innovation, maintain compliance, and support continuous inspection readiness across U.S. and global clinical programs. This job is based in San Diego, CA, or can be remote, and based in the US KEY RESPONSIBILITIES: Lead the design, implementation, and ongoing effectiveness of the Quality Management System (QMS) Establish policies, procedures, and governance frameworks covering core quality processes, including document control, change management, deviations, CAPA, training, and risk management Act as a strategic quality partner to Regulatory, Medical, Clinical Operations, R&D, and CMC teams Define and execute a quality roadmap that translates regulatory and quality requirements into practical, scalable operating models aligned with current compliance needs and future organizational growth Partner with Regulatory and Clinica...