Global Inspection Readiness Lead

Nalys

Waals-Brabant

On-site

EUR 90,000 - 130,000

Full time

7 days ago
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Job summary

Nalys is seeking an Inspection Management Lead to join a global quality team at a leading biopharmaceutical company. You will focus on inspection management and readiness to ensure compliance with GVP, GCP, and GLP, coordinating with internal teams and affiliates worldwide.

The role requires hands-on inspection experience, a regulatory mindset, and the ability to unite stakeholders around compliance. Fluency in English is essential; French is a strong asset.

Qualifications

  • 5+ years of experience in pharmacovigilance, GVP quality assurance or auditing.
  • Hands-on experience with inspections, ideally hosting inspections.
  • Experience with global health authorities and PV systems.

Responsibilities

  • Drive inspection readiness activities ahead of announced and unannounced inspections.
  • Prepare, support and host global inspections, including front room and back room coordination.
  • Review documentation to ensure alignment with regulatory expectations.
  • Provide quality oversight of pharma systems and processes worldwide.
  • Collaborate with cross-functional stakeholders and international affiliates to secure inspection outcomes.
  • Contribute to a culture of continuous compliance across the global landscape.

Skills

Pharmacovigilance
GVP quality
Auditing
Inspection readiness
Regulatory liaison
Stakeholder management
English proficiency
French language

Job description

Nalys is seeking an Inspection Management Lead to join a global quality team at a leading biopharmaceutical company. You will focus on inspection management and readiness to ensure compliance with GVP, GCP, and GLP, coordinating with internal teams and affiliates worldwide.

The role requires hands-on inspection experience, a regulatory mindset, and the ability to unite stakeholders around compliance. Fluency in English is essential; French is a strong asset.

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