Sr Manager, Quality Systems & Compliance

JOB SUMMARY

This role will assist in leading activities within 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. Quality Systems & Compliance 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 position can be remote based in the US or hybrid based in our San Diego headquarters.

KEY RESPONSIBILITIES

• Execute and support ongoing effectiveness of the Quality Management System (QMS).

• Work closely with Quality management to manage deviations and investigations, CAPA, change controls, risk assessments, quality events, and effectiveness checks internally and while working with external partners and suppliers/vendors

• Create controlled documents and governance frameworks covering core processes from establishment throughout continuous improvement efforts

• Support regulatory compliance within drug producti