Job Details

Overview 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.ResponsibilitiesLead 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 managementAct as a strategic quality partner to Regulatory, Medical, Clinical Operations, R&D, and CMC teamsDefine and execute a quality roadmap that translates regulatory and quality requirements into practical, scalable operating models aligned with current compliance needs and future organizational growthPartner with Regulatory and Clinical teams to ensure quality systems support global clinical trial programs, including alignment across regionsProactively identify and mitigate compliance risk through data-driven monitoring and governanceDefine key quality metrics and dashboards to monitor system health, compliance trends, and continuous improvement opportunitiesFoster a culture of accountability, transparency, and quality ownership across the organizationProvide quality oversight and coordination for health authority interactions, internal audits, and third-party audits, as applicableEnsure inspection readiness for U.S. and global clinical programs through established quality systems, governance, and cross-functional alignmentQualificationsEducation & Experience:Bachelor's degree in chemistry, biology, engineering, or related health science10+ years of progressive experience in Quality Systems, Compliance, and/or Quality leadership within a regulated industryExperience designing, implementing, or improving Quality Management SystemsExperience leading initiatives, projects, or teams in matrixed or growing organizationsExperience partnering with cross-functional teams, including Regulatory, Medical, Clinical Operations, R&D, and TechnologyStrong understanding of risk-based quality systems and continuous improvement conceptsAbility to define and use quality metrics to monitor system performance and compliance trendsClear, effective communicator with the ability to influence and align stakeholdersComfortable operating in environments with evolving processes and prioritiesExperience with electronic quality management systems (eQMS); Veeva experience a plusFamiliarity with global regulatory expectations applicable to clinical development, including U.S. and international considerationsWorking knowledge of GCP and applicable GMP principles as they relate to clinical quality systemsExperience supporting inspection readiness, audits, or regulatory interactions through quality systems and cross-functional collaborationDemonstrated ability to translate regulatory and quality requirements into practical, scalable processes#J-18808-Ljbffr