Principal Auditor, Quality Audits
Core
Lead complex, high-risk internal and external quality audits (GMP/GDP, ISO 13485, GxP) for pharmaceutical/biotech/medical device sites across Europe and Rest of World, ensuring inspection readiness and regulatory compliance.
Role type
Principal Quality Auditor (Senior IC)
Builds
Inspection-ready audit reports and robust quality governance for critical suppliers and manufacturing sites
Domain
Life Sciences / Pharmaceutical Quality Assurance / Regulatory Compliance
Required skills
GMP/GDP auditing, ISO 13485, GxP regulatory frameworks (EMA, FDA), CAPA management, risk-based auditing, supplier oversight, audit planning and execution, stakeholder engagement, remediation strategy
Preferred skills
Coaching and mentoring auditors, advanced terminal degree (MD, PhD, PharmD)
Technologies
GMP, GDP, ISO 13485, GxP, EMA, FDA
Responsibilities
Plan and execute complex internal and external audits; Lead for-cause audits of critical suppliers; Review and approve CAPA responses; Coach auditors; Provide expert input for regulatory interactions; Influence remediation strategies
Seniority
Principal, Senior IC
