Director, Quality Systems & Compliance
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
QUALIFICATIONS
Education & Experience:
• Bachelor’s degree in chemistry, biology, engineering, or related health science
Experience:
• 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
ABOUT IAMBIC THERAPEUTICS
Iambic is a clinical-stage life-science and technology company developing novel medicines using its AI-driven discovery and development platform. Based in San Diego and founded in 2020, Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters. The Iambic platform has demonstrated delivery of new drug candidates to human clinical trials with unprecedented speed and across multiple target classes and mechanisms of action. Iambic is advancing a pipeline of potential best-in-class and first-in-class clinical assets, both internally and in partnership, to address urgent unmet patient need. Learn more about the Iambic team, platform, pipeline, and partnerships at iambic.ai.
MISSION & CORE VALUES
Our mission is to deliver better medicines through innovations in AI-based discovery technologies. The culture and work at Iambic Therapeutics are profoundly strengthened by the diversity of our people and our differences in background, culture, national origin, religion, sexual orientation, and life experiences. We are committed to building an inclusive environment where a diverse group of talented humans work together to discover therapeutics and create technologies.
PAY AND BENEFITS
We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life insurance, 401K matching, and uncapped vacation to our team. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play.
Apply Now
Apply Now
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
QUALIFICATIONS
Education & Experience:
• Bachelor’s degree in chemistry, biology, engineering, or related health science
Experience:
• 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
ABOUT IAMBIC THERAPEUTICS
Iambic is a clinical-stage life-science and technology company developing novel medicines using its AI-driven discovery and development platform. Based in San Diego and founded in 2020, Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters. The Iambic platform has demonstrated delivery of new drug candidates to human clinical trials with unprecedented speed and across multiple target classes and mechanisms of action. Iambic is advancing a pipeline of potential best-in-class and first-in-class clinical assets, both internally and in partnership, to address urgent unmet patient need. Learn more about the Iambic team, platform, pipeline, and partnerships at iambic.ai.
MISSION & CORE VALUES
Our mission is to deliver better medicines through innovations in AI-based discovery technologies. The culture and work at Iambic Therapeutics are profoundly strengthened by the diversity of our people and our differences in background, culture, national origin, religion, sexual orientation, and life experiences. We are committed to building an inclusive environment where a diverse group of talented humans work together to discover therapeutics and create technologies.
PAY AND BENEFITS
We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life insurance, 401K matching, and uncapped vacation to our team. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play.
Apply Now
Apply Now