Director of Quality Systems and Compliance

iambic therapeuticsSan Diego HQ

Remote Full-time

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Experience Level

Senior Level Manager

Qualifications

Education & Experience:Bachelor’s degree in chemistry, biology, engineering, or a related health science. Experience:A minimum of 10 years of progressive experience in Quality Systems, Compliance, and/or Quality leadership within a regulated industry.

About the job

This position is based in our San Diego headquarters or can be performed remotely within the United States.

KEY RESPONSIBILITIES

Spearhead the design, implementation, and continuous improvement of the Quality Management System (QMS).
Develop policies, procedures, and governance frameworks governing essential quality processes, including document control, change management, deviations, CAPA, training, and risk management.
Serve as a strategic quality partner to Regulatory, Medical, Clinical Operations, R&D, and CMC teams.
Create and execute a quality roadmap that translates regulatory and quality requirements into scalable operational models, aligned with current compliance needs and future organizational growth.
Collaborate with Regulatory and Clinical teams to ensure quality systems effectively support global clinical trial programs, ensuring alignment across regions.
Proactively identify and mitigate compliance risks through data-driven monitoring and governance.
Establish key quality metrics and dashboards to track system health, compliance trends, and opportunities for continuous improvement.
Cultivate a culture of accountability, transparency, and quality ownership throughout the organization.
Oversee quality interactions with health authorities, internal audits, and third-party audits as necessary.
Ensure inspection readiness for U. S. and global clinical programs through established quality systems, governance, and cross-functional collaboration.

QUALIFICATIONS

Education & Experience:

Bachelor’s degree in chemistry, biology, engineering, or a related health science.
Experience:
A minimum of 10 years of progressive experience in Quality Systems, Compliance, and/or Quality leadership within a regulated industry.

About iambic therapeutics

iambic therapeutics is a cutting-edge organization dedicated to advancing innovative therapies in the healthcare sector. Our mission is to leverage our expertise and resources to deliver high-quality solutions that improve patient outcomes and contribute to the evolution of medical science.

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