Senior QA Manager – Pharma (GxP) + Stock Options

SpyGlass Pharma, Inc.; Irvine (CA); On-site; USD 160,000 - 180,000; Full time

Benefits offered by this job

Stock options

Annual bonus

Health, dental, vision insurance

Generous paid time off

Job summary

SpyGlass Pharma is seeking a Senior Manager of Quality Assurance to support R&D and Operations, ensuring processes meet regulatory and company QMS requirements. Reports to the Senior Director of Quality with oversight of one QA member, and collaborates across clinical and manufacturing operations toward commercialization.

The role requires extensive QA expertise, cGMP/GLP/GCP knowledge, and experience with drug/device combination products.

Qualifications

• B.S. in Chemistry, Biology, Engineering or related science.
• 10+ years in pharma with 5+ years in QA.
• 3+ years of people management or leadership experience.
• Deep QA methodologies to support development to commercial.
• Clinical development experience (Phase 2–3).
• Knowledge of FDA regs (cGMP/GLP/GCP/QMSR/ISO) and ICH guidelines.
• Experience with drug/device combo products and 21 CFR Part 4.
• Experience hosting/regulatory inspections (FDA or others).
• Strong analytical and problem-solving skills.
• Vendor/CMO engagement experience and audits.
• Ability to influence cross-functional stakeholders.
• Attention to detail and strong delegation.
• Strong verbal and technical writing skills.
• Mentoring QA team members.

Responsibilities

• Provide direct leadership, coaching, and performance management for the QA Engineer; set priorities and development plans.
• Maintain QMS compliance with drug and medical device regulations (21 CFR Part 210/211, Part 820/ISO 13485).
• Manage GxP quality requirements supporting product development and lifecycle management.
• Provide QA oversight for clinical and commercial product manufacturing, testing, storage, and distribution.
• Review and approve records, COAs, specifications, investigations, deviations, CAPA, and certificates of conformance.
• Perform product release for clinical and commercial distribution; manage raw material qualification.
• Review validation protocols and reports; approve change controls impacting product quality.
• Serve as representative with CMOs and coordinate with technical operations on issues.
• Own QA SOPs and lifecycle; author revisions; support management reviews and data prep.
• Lead QA initiatives and continuous improvement projects.
• Understand/regulatory guidance for GMP requirements and inspections readiness.
• Collaborate with Regulatory Affairs, Clinical Ops, Medical Affairs, Manufacturing and R&D.
• Other duties as assigned.

Skills

People management

Quality assurance

GxP compliance

Regulatory inspections

Risk-based decisions

Vendor/CMO management

Documentation control

Cross-functional collaboration

Process improvement

cGMP/GLP/GCP knowledge

Education

B.S. in Chemistry, Biology, Engineering or related science

Job description

SpyGlass Pharma is seeking a Senior Manager of Quality Assurance to support R&D and Operations, ensuring processes meet regulatory and company QMS requirements. Reports to the Senior Director of Quality with oversight of one QA member, and collaborates across clinical and manufacturing operations toward commercialization.

The role requires extensive QA expertise, cGMP/GLP/GCP knowledge, and experience with drug/device combination products.