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Iambic Therapeutics, a clinical-stage biotech company founded in 2020 and based in San Diego, is seeking a Senior Manager of Quality Systems & Compliance to lead the design and implementation of a comprehensive Quality Management System (QMS) supporting clinical development programs and the growing pipeline.
In this role, you will partner 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 include:
- Execute and support ongoing effectiveness of the QMS
- Manage deviations, investigations, CAPA (Corrective and Preventive Actions), change controls, risk assessments, and quality events internally and with external partners/vendors
- Create controlled documents and governance frameworks covering core processes
- Support regulatory compliance within drug production activities
- Execute a quality roadmap translating regulatory requirements into scalable operating models
- Proactively identify and mitigate compliance risk through data-driven monitoring
- Foster a culture of accountability, transparency, and quality ownership
- Provide quality oversight and coordination for internal and third-party audits
- Prepare the organization for inspection readiness through established quality systems and cross-functional alignment
Required qualifications:
- Bachelor's degree in a scientific or technical field (biology, chemistry, engineering, or related health science)
- 6+ years of progressive quality experience in GxP-regulated industries
- Experience supporting inspection readiness, audits, and regulatory interactions
- Demonstrated experience managing, implementing, or improving a QMS
- Proficiency with electronic quality management systems (eQMS) such as Veeva, ZenQMS, or MasterControl
- Familiarity with global regulatory expectations for clinical development (U.S. and international)
- Working knowledge of GCP and GMP principles as they relate to quality systems
- Strong understanding of risk-based quality systems and continuous improvement
- Experience leading cross-functional teams including Regulatory, CMC, Clinical Operations, IT, and R&D
- Strong technical writing, organizational, and problem-solving skills
- Ability to translate regulatory and quality requirements into practical, scalable processes
Iambic is an AI-driven drug discovery and development company that has demonstrated delivery of new drug candidates to human clinical trials with unprecedented speed across multiple target classes. The company offers competitive compensation, company-paid healthcare, flexible spending accounts, 401K matching, uncapped vacation, and operates from a state-of-the-art San Diego facility with onsite gym and dining.
