QA Audit & Inspection Lead - GxP Readiness

Regulatory Jobs; Sunnyvale (CA); Sur place; USD 150 000 - 190 000; Plein temps

Résumé du poste

Intuitive Surgical is a global leader in robotic‑assisted surgery. The Quality Assurance Manager, Audits & Inspections, will lead GxP audit activities and oversee regulatory inspection readiness for FDA reviews, collaborating with Clinical Operations, Regulatory Affairs, and pharmacovigilance to mitigate risks and ensure compliant operations.

This hands‑on role requires deep experience with audits, CAPA, and regulatory inspections, with a focus on late‑stage development readiness in a fast‑paced

Qualifications

• 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.
• Hands‑on experience planning, conducting, documenting, and closing GxP audits.
• Experience conducting audits of CROs, CDMOs, laboratories, clinical sites, or other regulated service providers.
• Experience supporting FDA or other health‑authority regulatory inspections.
• Strong knowledge of FDA regulations, ICH guidance, and GxP requirements.
• Strong technical writing skills and ability to produce clear, evidence‑based audit reports and compliance assessments.

Responsabilités

• Develop and maintain a risk‑based annual and multi‑year GxP audit program covering internal functions, clinical studies, CROs, CDMOs, laboratories, pharmacovigilance providers, and other critical GxP vendors.
• Plan, schedule, conduct, document, and close GxP audits in accordance with approved procedures and applicable regulatory requirements.
• Develop audit plans, agendas, checklists, reports, observations, and follow‑up documentation.
• Evaluate audit observations for regulatory significance, systemic risk, and potential impact on product quality, subject protection, data integrity, and regulatory submissions.
• Track audit findings, commitments, CAPAs, and effectiveness activities through closure.
• Perform audit trending and provide periodic reporting of significant findings and emerging compliance risks to QA leadership.

Formation

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

Description du poste

Intuitive Surgical is a global leader in robotic‑assisted surgery. The Quality Assurance Manager, Audits & Inspections, will lead GxP audit activities and oversee regulatory inspection readiness for FDA reviews, collaborating with Clinical Operations, Regulatory Affairs, and pharmacovigilance to mitigate risks and ensure compliant operations.

This hands‑on role requires deep experience with audits, CAPA, and regulatory inspections, with a focus on late‑stage development readiness in a fast‑paced