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
Compliance Auditor x3 in Manchester employer: Lonza
Lonza in Slough is an exceptional employer, offering a dynamic work environment where innovation and collaboration thrive. As a Senior Scientist, you will benefit from a culture that prioritises employee growth through continuous learning opportunities and hands-on experience with cutting-edge technologies. The company's commitment to developing regulatory-compliant medicines ensures that your contributions are meaningful and impactful, making it a rewarding place to advance your career.
