Inspection Management Lead - Pharmacovigilance

Jefferson Wells Belgium; Waals-Brabant; Hybrid; EUR 90,000 - 125,000; Full time

Job summary

Jefferson Wells Belgium is seeking an Inspection Management Lead (GVP) to join our Global Quality organization. You will lead inspection readiness and management across the global Pharmacovigilance function, ensuring compliance with GVP, GCP, and GLP while coordinating with health authorities.

Based in a collaborative, international team with Europe and the US, the role offers exposure to global regulatory inspections, cross-functional collaboration, and the opportunity to strengthen patient

Qualifications

• 5–8 years of experience in Pharmacovigilance, GVP Quality, QA or Auditing.
• Strong experience in inspection management within a regulated environment.
• Experience preparing for and supporting regulatory inspections.
• Global, cross-functional work experience.
• Solid PV and GVP expertise.
• Experience with inspections by FDA, EMA, MHRA, and other authorities.
• Background in QA and regulatory compliance.
• Audit/inspection readiness and documentation review.
• Excellent stakeholder management and collaboration skills.
• Strong written and spoken English.

Responsibilities

• Lead and coordinate inspection readiness activities across the global PV organization.
• Support and manage regulatory inspections conducted by international health authorities.
• Collaborate with PV, Regulatory Affairs, Clinical Ops and Quality teams.
• Review and assess documentation for regulatory compliance.
• Support or host inspections, including front-room and back-room activities.
• Provide quality oversight of global PV systems and processes.
• Identify compliance risks and contribute to CAPAs.
• Drive continuous improvement in inspection preparedness and quality management.

Skills

Inspection management

Pharmacovigilance

Regulatory inspections

GVP knowledge

Stakeholder management

Communication

Education

Tools

PV systems

QMS

Job description

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.
• 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.
• 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.