Senior Manager, Quality Systems, Compliance
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Job Description
Senior Quality Systems and Compliance Manager supporting Iambic Therapeutics’ AI-driven medicines platform. Leading QMS implementation, audits, CAPA, and inspection readiness across clinical programs.
Responsibilities:
- Assist in leading activities within Quality Systems and Compliance
- Design and implement a Quality Management System supporting clinical development programs and the growing pipeline
- Execute and support ongoing QMS effectiveness
- Manage deviations and investigations, CAPA, change controls, risk assessments, quality events, and effectiveness checks
- Work with external partners and suppliers/vendors on quality activities
- Create controlled documents and governance frameworks for core processes and continuous improvement
- Support regulatory compliance within drug production activities
- Execute a quality roadmap translating regulatory and quality requirements into scalable operating models
- Identify and mitigate compliance risk through data-driven monitoring
- Foster accountability, transparency, and quality ownership across the organization
- Provide quality oversight and coordination for internal and third-party audits
- Prepare U.S.-based and global clinical programs for inspection readiness
- Partner with Regulatory, Medical, Clinical, R&D, and Technology leadership
Requirements:
- Bachelor’s degree in a scientific or technical field, such as biology, chemistry, engineering, or related health science
- 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 implementing and maintaining electronic quality management systems (eQMS) such as Veeva, ZenQMS, or MasterControl
- 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
- Must be currently authorized to work in the United States
- Must answer whether visa sponsorship is required
- Must have experience managing a validated eQMS
Benefits:
- Company paid healthcare
- Flexible spending accounts
- Voluntary life insurance
- 401K matching
- Uncapped vacation
- Onsite gym
- Dining at the San Diego facility
- Flexible remote or hybrid work arrangement
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