Compliance Auditor x3

Overview

In this role you drive global GMP compliance, safeguarding Lonza’s licenses and quality across biologics, cell and gene therapies, sterile products, APIs, and devices. You will lead high-impact cGMP audits worldwide and partner with manufacturing sites to improve standards and readiness for inspections. Travel is substantial as you support risk management and remediation across a diverse, global footprint. This is a high-visibility opportunity to shape compliance excellence within a mission-driven, collaborative culture.

Pay / Benefits

• agile career and dynamic working culture
• inclusive and ethical workplace
• benefits tailored to locality
• global benefits access

Responsibilities

• Advise sites on remediation actions and regulatory inspection readiness
• Provide GMP compliance guidance and best practices
• Perform supplier quality assessments and audits
• Act as single point of contact (SPOC) for assigned suppliers
• Monitor regulatory and compliance risks across business units
• Mentor and coach audit team members

Key requirements

• Mandatory MHRA or HPRA health authority inspector experience with cGMP inspections
• Lead, plan and execute global corporate cGMP audits across diverse sites
• Advise on regulatory compliance, risk assessment, remediation strategies, and inspection preparation
• Perform supplier assessments and act as global SPOC for suppliers
• Mentor junior auditors and drive continuous quality improvement
• 10+ years of cGMP QA/auditing experience with MSc in Chemistry, Biochemistry, Pharmacy, or related field
• mentoring and coaching
• leadership
• clear communication
• cGMP QA/auditing
• supplier quality assessments
• regulatory inspections readiness

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