Senior QA & Regulatory Compliance Specialist

Delve Bio, Inc.; San Francisco (CA); On-site; USD 110,000 - 130,000; Full time

Benefits offered by this job

Performance-based bonus

Comprehensive health insurance

Unlimited PTO

401(k) retirement plan

Professional development allowance

Job summary

Delve Bio, Inc. seeks a Senior Quality Assurance Specialist to operate and mature the QMS within a CLIA/CAP-accredited clinical laboratory. You will own core QA processes, maintain records, and prepare for inspections, while providing training and guidance to staff and peers.

This role offers growth in a fast-paced startup environment, with cross-functional collaboration and a focus on continuous improvement and compliance readiness.

Qualifications

• Bachelor’s degree in life science or related field.
• 3–5+ years QA experience in a CLIA/CAP clinical lab or regulated healthcare setting.
• Knowledge of CLIA (42 CFR 493), CAP checklists, and NYSDOH standards.
• Experience with document control in an electronic QMS and CAPA management.

Responsibilities

• Maintain the eQMS, track quality metrics, and prepare data for management review.
• Own document lifecycle management, including routing, revisions, and distribution.
• Lead investigations, CAPA tracking, and root cause analysis.
• Support internal audits and inspections (CAP, CLIA, NYSDOH).
• Maintain training records and deliver QMS training to staff.
• Track regulatory changes and assist with inspection responses.
• Identify process gaps and drive continuous improvement.

Skills

Attention to detail

Document control

Root cause analysis

Audits & inspections

Regulatory awareness

Communication

Education

Life science degree

Tools

Electronic QMS

Job description

Delve Bio, Inc. seeks a Senior Quality Assurance Specialist to operate and mature the QMS within a CLIA/CAP-accredited clinical laboratory. You will own core QA processes, maintain records, and prepare for inspections, while providing training and guidance to staff and peers.

This role offers growth in a fast-paced startup environment, with cross-functional collaboration and a focus on continuous improvement and compliance readiness.