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About the role
Key responsibilities & impact- Design, plan, and execute high-impact corporate cGMP audits across a diverse global footprint
- Partner directly with manufacturing sites to elevate standards, navigate complex regulatory landscapes, and ensure continuous inspection readiness
- Advise and support sites in developing and executing remediation actions
- Prepare for and manage regulatory inspections
- 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
- Support the global vision and strategic objectives for HR processes and technology, ensuring alignment with Lonza’s goals
Requirements
What you’ll need- Mandatory previous experience as a Health Authority Inspector with the MHRA or HPRA (Ireland) carrying out cGMP inspections
- Experience leading, planning, and executing global corporate cGMP compliance audits across diverse sites, including biologics, cell/gene therapies, sterile products, and APIs
- Experience advising sites on regulatory compliance, risk assessment, remediation strategies, and health authority inspection preparation
- Experience performing supplier assessments and acting as the global Single Point of Contact (SPOC) for assigned suppliers
- Experience mentoring junior auditors, providing senior compliance guidance, and driving continuous quality improvement across business units
- 10+ years of cGMP QA/auditing experience
- MSc (or equivalent) in Chemistry, Biochemistry, Pharmacy, or a related field
Benefits
Comp & perks- 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 https://www.lonza.com/careers/benefits
