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

📋 Description

• Design, plan, and implement impactful corporate cGMP audits across a wide-ranging global network.

• Collaborate directly with manufacturing sites to enhance standards, navigate intricate regulatory environments, and maintain ongoing inspection readiness.

• Provide guidance and assistance to sites in formulating and executing remediation plans.

• Prepare for and oversee regulatory inspections.

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

• Conduct Supplier Quality assessments and audits.

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

• Monitor and evaluate compliance risks across various business units.

• Mentor and coach auditors.

• Support the overarching vision and strategic goals for HR processes and technology, ensuring alignment with Lonza’s objectives.

⛳️ Requirements

• Previous experience as a Health Authority Inspector with the MHRA or HPRA (Ireland) conducting cGMP inspections is essential.

• Proven track record in leading, planning, and executing global corporate cGMP compliance audits across various sites, including biologics, cell/gene therapies, sterile products, and APIs.

• Experience in advising sites on regulatory compliance, risk assessment, remediation strategies, and preparation for health authority inspections.

• Background in performing supplier assessments and acting as the global Single Point of Contact (SPOC) for assigned suppliers.

• Experience in mentoring junior auditors, delivering senior compliance guidance, and promoting continuous quality improvement across business units.

• Over 10 years of experience in cGMP QA/auditing.

• MSc (or equivalent) in Chemistry, Biochemistry, Pharmacy, or a related discipline.