Senior Director, Quality Systems & Compliance

Location: Remote (San Diego/Hybrid -West Coast preferred, not required)

Position Overview

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.

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.

Qualifications

• Bachelor’s degree in chemistry, biology, engineering, or related health science.
• 10+ years of progressive experience in Quality Systems, Compliance, and/or Quality leadership within a regulated industry. 
• Experience designing, implementing, or improving Quality Management Systems.
• Experience leading initiatives, projects, or teams in matrixed or growing organizations.
• Experience partnering with cross-functional teams, including Regulatory, Medical, Clinical Operations, R&D, and Technology.
• Strong understanding of risk-based quality systems and continuous improvement concepts.
• Ability to define and use quality metrics to monitor system performance and compliance trends.
• Clear, effective communicator with the ability to influence and align stakeholders.
• Comfortable operating in environments with evolving processes and priorities.
• Experience with electronic quality management systems (eQMS); Veeva experience a plus.
• Familiarity with global regulatory expectations applicable to clinical development, including U.S. and international considerations.
• Working knowledge of GCP and applicable GMP principles as they relate to clinical quality systems.
• Experience supporting inspection readiness, audits, or regulatory interactions through quality systems and cross-functional collaboration.
• Demonstrated ability to translate regulatory and quality requirements into practical, scalable processes.