Compliance Auditor

🔥 14 hours ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🔎 Auditor

👻 Ghost score 10%

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Lonza

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1897

🧬 Biotechnology

💊 Pharmaceuticals

🏭 Manufacturing

💰 $444.8M Post-IPO Debt - Lonza on 2023-11

Biotechnology • Pharmaceuticals • Manufacturing

Lonza is a Swiss-based, global contract development and manufacturing organization (CDMO) and life sciences company. It provides integrated end-to-end offerings across biologics and small-molecule drug development and manufacturing — including cell line development, process and analytical development, formulation and primary packaging, drug substance and drug product manufacturing, and regulatory/CMC support. Lonza's capabilities span advanced synthesis and APIs (including HPAPIs), bioconjugation and ADCs, specialized modalities such as cell & gene therapies, mRNA/LNP, microbial processes, and capsule and health-ingredient products. Founded in Switzerland in 1897, Lonza describes itself as a pioneer and world leader in the CDMO industry and operates with ~20,000 colleagues across five continents to support pharmaceutical and biotech customers.

📋 Description

• Drive compliance excellence and mitigate quality risks worldwide • Design, plan, and execute high-impact corporate cGMP audits across biologics, cell and gene therapies, sterile drug products, APIs, medical devices, and hardware/software operations • Partner directly with manufacturing sites to elevate standards 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

🎯 Requirements

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

🏖️ Benefits

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

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