About the role
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 Clinical teams to ensure quality systems support global clinical trial programs, including alignment across regions. Proactively identify and mitigate compliance risk through data-driven monitoring and governance Define key quality metrics and dashboards to monitor system health, compliance trends, and continuous improvement opportunities Foster a culture of accountability, transparency, and quality ownership across the organization Provide quality oversight and coordination for health authority interactions, internal audits, and third-party audits, as applicable Ensure inspection readiness for U.S. and global clinical programs through established quality systems, governance, and cross-functional alignment