Quality Systems & Compliance Lead (QMS) - Remote/Hybrid

Iambic; San Diego (CA); Hybrid; USD 152,000 - 190,000; Full time

Benefits offered by this job

Company paid healthcare

401K matching

Uncapped vacation

Onsite gym

Dining facilities

Job summary

Iambic Therapeutics, based in San Diego, is seeking a Quality Systems & Compliance lead to design and implement a QMS supporting current clinical programs and a growing pipeline. You will partner with Regulatory, Medical, Clinical, R&D and Technology to enable quality and inspection readiness across US and global programs.

The role can be remote in the US or hybrid at the San Diego headquarters, offering influence across quality practices and compliance across the organization.

Qualifications

• Bachelor’s degree in a scientific or technical field and 6+ years in a GxP-regulated setting.
• Experience supporting inspection readiness, audits, or regulatory interactions.
• Experience leadership in implementing or improving a QMS.
• Experience with electronic quality management systems (eQMS).
• Familiarity with global regulatory expectations for clinical development.

Responsibilities

• Execute and support ongoing effectiveness of the Quality Management System (QMS).
• Collaborate with Quality management to manage deviations, investigations, CAPA, change controls, risk assessments, quality events, and effectiveness checks.
• Create controlled documents and governance frameworks for core processes.
• 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 and quality ownership across the organization.
• Provide quality oversight for internal and third-party audits.
• Prepare organization for inspection readiness for US and global programs.

Skills

Quality systems

GxP expertise

Regulatory alignment

Cross-functional leadership

Quality documentation

Audit coordination

Education

Bachelor’s degree in science/engineering

Tools

Veeva

ZenQMS

MasterControl

Job description

Iambic Therapeutics, based in San Diego, is seeking a Quality Systems & Compliance lead to design and implement a QMS supporting current clinical programs and a growing pipeline. You will partner with Regulatory, Medical, Clinical, R&D and Technology to enable quality and inspection readiness across US and global programs.

The role can be remote in the US or hybrid at the San Diego headquarters, offering influence across quality practices and compliance across the organization.