Compliance Auditor x3

AAPC; United States; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

An agile career and dynamic working文化

An inclusive and ethical workplace

A variety of benefits tailored to your

Access to global benefits via lonza.c"

Job summary

Lonza is seeking a Compliance Auditor to lead global cGMP audits across biologics, cell therapies, sterile products, and APIs, with substantial international travel (50–60%). You will design, plan, and execute audits and provide expert guidance to sites worldwide.

This high-visibility role partners with manufacturing sites to ensure inspection readiness, align with regulatory expectations, and continuously improve quality systems across business units.

Qualifications

• 10+ years of cGMP QA/auditing experience.
• Experience conducting global corporate cGMP audits across diverse sites.
• Experience working with MHRA or HPRA inspections.

Responsibilities

• Champion Global Excellence: Support the global vision and strategic objectives for HR processes and technology, ensuring alignment with Lonza's goals.
• Advise and support sites in developing and executing remediation actions, preparing for and managing regulatory inspections, and ensuring compliance.
• Provide GMP compliance expertise and best practice guidance.
• Perform Supplier Quality assessments and audits.
• Act as SPOC for assigned suppliers within a global portfolio.
• Monitor and assess compliance risks across business units.
• Mentor and coach auditors

Skills

Global audits

cGMP QA/auditing

Regulatory inspections guidance

SPOC for suppliers

Mentor auditors

Cross-functional collaboration

Education

MSc in Chemistry/ Biochemistry/ Pharmacy or related field

Job description

Compliance Auditor

This role involves significant international travel (50–60%) across global manufacturing sites and operational facilities.

As a Corporate Compliance Auditor, you will play a pivotal role in safeguarding Lonza's license to operate by driving compliance excellence and mitigating quality risks worldwide. Acting as a trusted technical advisor, you will design, plan, and execute high-impact corporate cGMP audits across a diverse global footprint—spanning biologics, cell and gene therapies, sterile drug products, APIs, medical devices, and hardware/software operations.

In this high-visibility global role, you will partner directly with manufacturing sites to elevate standards, navigate complex regulatory landscapes, and ensure continuous inspection readiness.

What you will get:

• An agile career and dynamic working culture
• An inclusive and ethical workplace
• A variety of benefits tailored to your locality.
• Access to global benefits via lonza.com/careers/benefits

What you will do:

• Champion Global Excellence: Support the global vision and strategic objectives for HR processes and technology, ensuring alignment with Lonza's goals.
• Advise and support sites in developing and executing remediation actions, preparing for and managing regulatory inspections, and ensuring compliance.
• Provide GMP compliance expertise and best practice guidance.
• Perform Supplier Quality assessments and audits.
• Act as SPOC for assigned suppliers within a global portfolio.
• Monitor and assess compliance risks across business units.
• Mentor and coach auditors

What we are looking for:

• Mandatory previous experience as a Health Authority Inspector with the MHRA or HPRA (Ireland) carrying out cGMP inspections.
• Lead, plan, and execute global corporate cGMP compliance audits across diverse sites, including biologics, cell/gene therapies, sterile products, and APIs.
• Advise sites on regulatory compliance, risk assessment, remediation strategies, and health authority inspection preparation.
• Perform supplier assessments and act as the global Single Point of Contact (SPOC) for assigned suppliers.
• Mentor junior auditors, provide senior compliance guidance, and drive continuous quality improvement across business units.
• 10+ years of cGMP QA/auditing experience paired with an MSc (or equivalent) in Chemistry, Biochemistry, Pharmacy, or a related field.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.