Inspection Management Lead - Pharmacovigilance

Contracting - Brabant Wallon

About the Role

Our client, a leading global biopharmaceutical company, is looking for an Inspection Management Lead (GVP) to join its Global Quality organization.

In this role, you will be responsible for leading inspection management and inspection readiness activities across the organization's global Pharmacovigilance (PV) function.

You will help ensure compliance with international regulatory requirements, including GVP, GCP, and GLP, while supporting interactions with health authorities worldwide.

You will work within a small, highly collaborative international team based across Europe and the United States, supporting affiliates and stakeholders globally.

Key Responsibilities

• Lead and coordinate inspection readiness activities across the global Pharmacovigilance organization.
• Support and manage regulatory inspections conducted by international health authorities.
• Collaborate closely with cross-functional stakeholders, including Pharmacovigilance, Regulatory Affairs, Clinical Operations, and Quality teams.
• Review and assess documentation to ensure compliance with regulatory requirements and expectations.
• Support or host inspections, including both front-room and back-room activities.
• Provide quality oversight of global PV systems, processes, and compliance activities.
• Identify compliance risks and contribute to the implementation of corrective and preventive actions (CAPAs).
• Drive continuous improvement initiatives related to inspection preparedness and quality management.

Required Qualifications

Experience

• Minimum 5–8 years of experience in Pharmacovigilance, GVP Quality, Quality Assurance, or Auditing.
• Strong and demonstrable experience in inspection management within a regulated environment.
• Experience preparing for and supporting regulatory inspections.
• Experience working in a global and cross-functional environment.

Essential Skills

• Strong expertise in Pharmacovigilance (PV) and Good Pharmacovigilance Practices (GVP).
• Proven experience with inspections conducted by global regulatory authorities, such as FDA, EMA, MHRA, and other health authorities.
• Solid background in quality assurance and regulatory compliance.
• Experience in audit/inspection readiness and documentation review.
• Excellent stakeholder management and collaboration skills.
• Strong communication and presentation skills.
• Fluent English, both written and spoken.

Nice to Have

• Experience conducting or supporting internal and external audits.
• French language skills.
• Experience with Pharmacovigilance systems, vendors, and Quality Management Systems (QMS).
• Exposure to global and matrix-based organizations.

What we offer

• A strategic role with global visibility.
• Exposure to international regulatory inspections and compliance activities.
• A collaborative and multicultural working environment.
• Hybrid working model with flexibility and regular on-site collaboration.
• The opportunity to contribute to patient safety and quality excellence on a global scale.