Director, Quality Systems & Compliance

Iambic Therapeutics, Inc•San Diego, CA

1d•Remote

About The Position

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

Requirements

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.
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

Nice To Haves

Experience with electronic quality management systems (eQMS); Veeva experience a plus

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