Compliance Auditor

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Ensure the highest standards of compliance and minimize quality risks on a global scale.

• Create, strategize, and implement impactful corporate cGMP audits for biologics, cell and gene therapies, sterile drug products, APIs, medical devices, and hardware/software operations.

• Collaborate closely with manufacturing facilities to enhance standards and maintain ongoing readiness for inspections.

• Provide guidance and support to sites in formulating and executing corrective actions.

• Prepare for and oversee regulatory inspections.

• Offer expertise in GMP compliance and share best practice recommendations.

• Conduct Supplier Quality evaluations and audits.

• Serve as the Single Point of Contact (SPOC) for designated suppliers within a global framework.

• Evaluate and monitor compliance risks across various business units.

• Train and guide auditors.

⛳️ Requirements

• Essential prior experience as a Health Authority Inspector with the MHRA or HPRA (Ireland) conducting cGMP inspections.

• Lead, organize, and carry out global corporate cGMP compliance audits across a range of sites, including biologics, cell/gene therapies, sterile products, and APIs.

• Provide advice to sites on regulatory compliance, risk evaluation, remediation plans, and preparations for health authority inspections.

• Conduct supplier evaluations and act as the global Single Point of Contact (SPOC) for designated suppliers.

• Mentor junior auditors, deliver senior compliance insights, and promote continuous quality enhancement across business units.

• Over 10 years of cGMP QA/auditing experience.

• Master’s degree (or equivalent) in Chemistry, Biochemistry, Pharmacy, or a related discipline.

🏝️ Benefits

• A flexible career path and a vibrant working environment.

• A workplace that is inclusive and ethical.

• A range of benefits customized to your locality.

• Access to global benefits through https://www.lonza.com/careers/benefits.