Senior QA Leader, Drug/Device Compliance & Lifecycle

Run my Accounts AG; Irvine (CA); On-site; USD 160,000 - 180,000; Full time

Benefits offered by this job

Stock options

Annual bonus opportunity

Health, dental, vision insurance

Job summary

SpyGlass Pharma is seeking a Senior Manager of Quality Assurance to support R&D and Operations, ensuring compliance with cGMP, GCP, and GLP across development and manufacturing. You will oversee QA processes, document control, supplier qualification, deviations, CAPA, and batch disposition while partnering with CMOs and internal teams.

You will mentor QA staff, drive continuous improvement projects, and prepare for regulatory inspections as the company advances toward commercialization.

Qualifications

• B.S. in Chemistry, Biology, Engineering or related science.
• 10+ years of pharmaceutical QA experience with at least 5 years in QA roles.
• 2+ years of people management or team leadership.

Responsibilities

• Lead QA engineer team with coaching and performance management.
• Maintain QMS compliance with drug and medical device regs (21 CFR 210/211, 820, ISO 13485).
• Oversee QA for product development, clinical and commercial manufacturing.
• Review and approve records, deviations, CAPA, certificates of conformance.
• Perform product release for clinical and commercial distribution.
• Collaborate with Regulatory Affairs, Clinical Operations, Manufacturing and R&D.
• Support regulatory inspections and inspections readiness.

Skills

People management

Quality decision making

Regulatory knowledge

Analytical skills

Vendor engagement

Cross-functional collaboration

Communication

Problem solving

Education

B.S. in Chemistry, Biology, Engineering

Tools

ASQ CQE/CQA

Job description

SpyGlass Pharma is seeking a Senior Manager of Quality Assurance to support R&D and Operations, ensuring compliance with cGMP, GCP, and GLP across development and manufacturing. You will oversee QA processes, document control, supplier qualification, deviations, CAPA, and batch disposition while partnering with CMOs and internal teams.

You will mentor QA staff, drive continuous improvement projects, and prepare for regulatory inspections as the company advances toward commercialization.