Global Compliance Auditor – cGMP Inspections (Remote)

Remote Worker LTD.; United States; Remote; USD 140,000 - 180,000; Full time

Benefits offered by this job

An agile career and dynamic working文化

Job summary

Lonza is seeking a Compliance Auditor to lead global cGMP audits across biologics, cell and gene therapies, sterile products, APIs, and devices. You will partner with manufacturing sites to maintain inspection readiness and drive compliance excellence on a 50–60% international travel schedule.

Candidates must have 10+ years of cGMP QA/auditing experience and a MSc in Chemistry, Biochemistry, Pharmacy, or related field, with prior health authority inspection exposure.

Qualifications

• 10+ years of cGMP QA/auditing experience.
• Experience as Health Authority Inspector with MHRA or HPRA is required.

Responsibilities

• Design, plan, and execute global corporate cGMP audits across diverse sites.
• Advise sites on regulatory compliance, risk assessment, remediation strategies, and inspection preparation.
• Provide GMP compliance expertise and best practice guidance.
• Mentor junior auditors and drive continuous quality improvement.

Skills

Audit planning

Regulatory guidance

Mentoring auditors

Supplier QA

Global auditing

Education

MSc in Chemistry/Biochemistry/Pharmacy or related field

Job description

Lonza is seeking a Compliance Auditor to lead global cGMP audits across biologics, cell and gene therapies, sterile products, APIs, and devices. You will partner with manufacturing sites to maintain inspection readiness and drive compliance excellence on a 50–60% international travel schedule.

Candidates must have 10+ years of cGMP QA/auditing experience and a MSc in Chemistry, Biochemistry, Pharmacy, or related field, with prior health authority inspection exposure.