Associate Director – Global Auditing

MSD

Haarlem

On-site

EUR 120,000 - 190,000

Full time

12 days ago

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Job summary

MSD in Haarlem region seeks an Associate Director Auditor to drive GMP/GDP audits across manufacturing sites, suppliers, and partners across Europe and beyond. You will assess compliance, support due diligence, and document findings to enable risk mitigation and continuous improvement.

You will lead audits within GMP environments, collaborating with manufacturing, quality, and supply chain teams while traveling up to 50% to diverse locations and facilities worldwide.

Qualifications

  • 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.
  • Auditing experience within GMP-regulated environments.

Responsibilities

  • Conduct GMP and GDP audits across sites, suppliers, and distribution networks.
  • Assess regulatory compliance, quality systems, and industry standards.
  • Support due diligence, supplier qualification, and inspection readiness.
  • Plan, conduct, and document audits with clear observations and recommendations.
  • Collaborate with manufacturing, quality, supply chain, and compliance functions.
  • Maintain knowledge of evolving regulatory requirements and best practices.
  • Support projects to enhance audit programme effectiveness and efficiency.
  • Influence quality and compliance standards across a global network.

Skills

GMP Auditing
Quality Risk Management
Regulatory Compliance
Auditing
Stakeholder Management
Technical Writing
Influencing Skills
Cross-Team Collaboration
Global Team Collaboration
Problem Solving
Inspection Readiness
Pharmaceutical Industry
Travel Flexibility

Education

Science/Engineering/Chemistry/Biology degree

Job description

Job Description

Join a global quality organisation and play a key role in safeguarding product quality, compliance, and patient supply across an international manufacturing and supply network.

As an Associate Director Auditor, you will conduct audits across manufacturing sites, suppliers, contractors, and distribution partners throughout Europe and beyond. This role offers unique exposure to a broad range of technologies, products, and manufacturing environments, including biologics, sterile products, vaccines, APIs, and emerging therapies.

Working as part of a highly experienced global audit team, you will help assess compliance, identify risk, and drive continuous improvement across a complex global supply chain. The successful candidate can be based anywhere in Europe and should be comfortable with regular international travel.

Bring energy, knowledge, and innovation to carry out the following:

  • 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 activities, supplier qualification, and pre-approval inspection readiness assessments.
  • Prepare for, conduct, and document audits, ensuring clear and timely reporting of observations and recommendations.
  • Partner with stakeholders across manufacturing, quality, supply chain, and compliance functions to support risk mitigation and continuous improvement.
  • Maintain knowledge of evolving regulatory requirements, industry trends, and best practices.
  • Support projects and initiatives that enhance audit programme effectiveness and efficiency.
  • Influence quality and compliance standards across a diverse global manufacturing network.
  • Build strong relationships with internal and external stakeholders while operating independently across multiple locations and cultures.

What Skills You Will Need

  • 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 effectively across global teams.
  • Willingness to travel regularly across Europe and other international locations.
  • Comfortable with travel, up to 50%.

Required Skills:

Adaptability, Cross-Team Collaboration, Global Team Collaboration, GMP Auditing, Influencing Skills, Inspection Readiness, Pharmaceutical Industry, Pharmaceutical Supply Chain, Problem Solving, Quality Risk Management, Regulatory Compliance, Stakeholder Management, Technical Writing

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

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