Associate Director – Global Auditing

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🔥 0 minutes ago

🌐 Ireland, Netherlands, +3 more countries – Remote

🇮🇪 Ireland – Remote 🇳🇱 Netherlands – Remote 🇫🇷 France – Remote 🇮🇹 Italy – Remote 🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

👔 Director

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MSD

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1891

🏥 Healthcare

📦 Logistics

🧬 Biotechnology

Healthcare • Logistics • Biotechnology

MSD is a leading biopharmaceutical company known as Merck & Co. , Inc. in the United States, Canada, and Puerto Rico, and as MSD globally. The company focuses on scientific innovation to deliver medicines and vaccines for various health challenges, including oncology, vaccines, infectious diseases, and cardio-metabolic diseases. MSD operates multiple divisions, including Human Health, Animal Health, and Research & Development. With approximately 75,000 employees worldwide and a significant investment in research and development, MSD is committed to improving global health through its scientific advancements. Additionally, the company places a strong emphasis on diversity, inclusion, and corporate responsibility. MSD’s operations extend worldwide, offering opportunities in numerous regions and promoting diversity and innovation in all aspects of its business.

📋 Description

• Conduct GMP and GDP audits across manufacturing sites, suppliers, contractors, business partners, and distribution networks • Assess compliance with regulatory requirements, quality systems, and industry standards • Support due diligence, supplier qualification, and pre-approval inspection readiness assessments • Prepare, conduct, and document audits, with clear and timely reporting of observations and recommendations • Partner with manufacturing, quality, supply chain, and compliance stakeholders on risk mitigation and continuous improvement • Maintain knowledge of evolving regulatory requirements, industry trends, and best practices • Support projects improving audit programme effectiveness and efficiency • Influence quality and compliance standards across a global manufacturing network • Build relationships with internal and external stakeholders while operating independently across locations and cultures • Travel regularly across Europe and other international locations, up to 50%

🎯 Requirements

• Degree in Science, Engineering, Chemistry, Biology, or a related discipline • Significant experience within the pharmaceutical industry or as a regulator • Strong knowledge of GMP requirements and quality systems supporting pharmaceutical manufacturing • Experience in Quality, Manufacturing, Compliance, Auditing, or related regulated functions • Previous auditing experience within GMP-regulated environments • Experience in biologics, sterile, or other complex pharmaceutical operations is advantageous • Strong understanding of quality risk management, regulatory expectations, and compliance principles • Excellent communication, influencing, negotiation, and report-writing skills • Ability to work independently while collaborating across global teams • Willingness to travel regularly across Europe and internationally • Comfortable with travel up to 50%

🏖️ Benefits

• Flexible working where possible • Remote work arrangement • Equal opportunity and inclusive workplace • Support during the recruitment process