Sr Manager, Quality Systems & Compliance

About this role

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 production activities

- Execute a quality roadmap that translates regulatory and quality requirements into practical, scalable operating models aligned with current compliance needs and future organizational growth

- Proactively identify and mitigate compliance risk through data-driven monitoring

- Foster a culture of accountability, transparency, and quality ownership across the organization

- Provide quality oversight and coordination for internal and third-party audits

- Prepare the organization for inspection readiness for U.S.-based and global clinical programs through established quality systems, governance, and cross-functional alignment.

QUALIFICATIONS

- Bachelor’s degree in a scientific or technical field, such as biology, chemistry, engineering, or related health science, with 6+ years of progressive Quality experience within a GxP-regulated industry

- Experience supporting inspection readiness, audits, or regulatory interactions through quality systems and cross-functional collaboration

- Experience managing, implementing or improving a Quality Management System

- Experience with implementing and maintaining electronic quality management systems (eQMS) such as Veeva, ZenQMS, MasterControl, etc.

- 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 quality systems

- Strong understanding of risk-based quality systems and continuous improvement concepts

- Experience partnering and leading cross-functional teams, including Regulatory, CMC, Clinical Operations, Information Technology and R&D

- Strong technical writing, organizational, and problem-solving skills.

- 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 http://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.

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