Onsite QA Manager, GxP Audits & Inspections

Intuitive; Sunnyvale (CA); On-site; USD 180,000 - 270,000; Full time

Job summary

Intuitive is seeking a QA Manager, Audits & Inspections to lead GxP audit programs and maintain FDA/regulatory inspection readiness through Phase 3 and beyond. The role partners with Clinical Operations and Regulatory teams to identify risks, manage observations, and drive CAPAs with strong cross-functional collaboration.

The candidate will oversee internal, external, and vendor audits, support inspection readiness activities, and mentor teams in inspection practices, documentation, and response

Qualifications

• Bachelor’s degree in life sciences, pharmacy, chemistry, engineering, or related discipline.
• Minimum of 7 years QA in pharmaceutical/biotech or regulated life sciences.
• Hands-on experience planning, conducting, closing GxP audits.
• Experience with FDA or health authority inspections.
• Strong written communication and audit reporting skills.

Responsibilities

• Develop and maintain a risk-based GxP audit program.
• Plan, conduct, document, and close GxP audits.
• Develop audit plans, agendas, reports, and follow-up docs.
• Track audit findings and CAPAs through closure.
• Provide periodic reporting of significant findings to QA leadership.
• Develop and maintain inspection-readiness program for FDA and health authorities.
• Coordinate inspection logistics and SME preparation.
• Review responses for regulatory defensibility.
• Track post-inspection commitments and CAPAs.
• Conduct qualification and audits of CROs, CDMOs, labs.
• Provide training to teams on inspector interactions.

Skills

Auditing

Regulatory compliance

Quality assurance

GxP knowledge

FDA familiarity

Education

Bachelor’s degree in life sciences, pharmacy, chemistry, engineering, or another relevant discipline

Minimum of 7 years of progressive pharmaceutical, biotechnology, or regulated life-sciences Quality Assurance experience

Job description

Intuitive is seeking a QA Manager, Audits & Inspections to lead GxP audit programs and maintain FDA/regulatory inspection readiness through Phase 3 and beyond. The role partners with Clinical Operations and Regulatory teams to identify risks, manage observations, and drive CAPAs with strong cross-functional collaboration.

The candidate will oversee internal, external, and vendor audits, support inspection readiness activities, and mentor teams in inspection practices, documentation, and response