Inspection Management Quality Lead

ELMEA Consulting Group; Eigenbrakel; À distance; EUR 90 000 - 120 000; Plein temps

Résumé du poste

ELMEA Consulting Group is seeking a Pharmacovigilance Quality Lead to join an international pharmaceutical company in Belgium. You will support global pharmacovigilance quality, regulatory compliance and inspection readiness.

The role requires 8+ years in PV QA, proven experience hosting inspections, and strong knowledge of GVP/Gx. You will lead PV quality systems, CAPA, audits and cross-functional collaboration with stakeholders worldwide.

Qualifications

• 8+ years of Pharmacovigilance Quality Assurance, PV Compliance, GVP, or PV Auditing.
• Proven experience managing and/or hosting pharmacovigilance inspections (mandatory).
• Strong knowledge of global PV regulations, particularly GVP, and applicable regulatory requirements.
• Experience with PV quality systems, audits, CAPAs, inspection preparation, and documentation management.
• Experience working within the pharmaceutical or biotechnology industry.
• Ability to collaborate effectively with international stakeholders and manage quality-related activities across teams.
• Excellent written and spoken English (mandatory).

Responsabilités

• Lead and coordinate pharmacovigilance inspection readiness activities, including preparation for and hosting of regulatory authority inspections.
• Ensure compliance with global pharmacovigilance regulations and guidelines, including GVP, GCP, FDA, EMA, and MHRA requirements.
• Oversee and continuously improve PV quality management systems, processes, and procedures.
• Coordinate PV audits, inspection documentation, findings, and follow-up activities.
• Manage CAPAs, ensuring appropriate corrective and preventive actions are implemented and tracked.
• Collaborate with global cross-functional teams and external service providers to maintain quality standards and regulatory compliance.
• Support continuous improvement initiatives and promote a strong quality and compliance culture across the organisation.

Connaissances

Pharmacovigilance QA

GVP compliance

Auditing

Regulatory inspections

CAPA management

Cross-functional collab

English fluency

Outils

Veeva

Argus

Description du poste

As a Pharmacovigilance Quality Lead, you will join an international pharmaceutical company based in Braine-l’Alleud and support global pharmacovigilance quality, regulatory compliance, and inspection readiness.

This role is ideal for a senior professional with strong expertise in PV Quality Assurance, GVP compliance, auditing, and regulatory inspection management.

Challenges we trust you with

• Lead and coordinate pharmacovigilance inspection readiness activities, including preparation for and hosting of regulatory authority inspections.
• Ensure compliance with global pharmacovigilance regulations and guidelines, including GVP, GCP, FDA, EMA, and MHRA requirements.
• Oversee and continuously improve PV quality management systems, processes, and procedures.
• Coordinate PV audits, inspection documentation, findings, and follow-up activities.
• Manage CAPAs, ensuring appropriate corrective and preventive actions are implemented and tracked.
• Collaborate with global cross-functional teams and external service providers to maintain quality standards and regulatory compliance.
• Support continuous improvement initiatives and promote a strong quality and compliance culture across the organisation.

Required profile.

• 8+ years of experience in Pharmacovigilance Quality Assurance, PV Compliance, GVP, or PV Auditing.
• Proven experience managing and/or hosting pharmacovigilance inspections (mandatory).
• Strong knowledge of global PV regulations, particularly GVP, and applicable regulatory requirements.
• Experience with PV quality systems, audits, CAPAs, inspection preparation, and documentation management.
• Experience working within the pharmaceutical or biotechnology industry.
• Ability to collaborate effectively with international stakeholders and manage quality-related activities across teams.
• Excellent written and spoken English (mandatory).

Nice to have:

• Experience with Veeva and/or Argus.
• Experience overseeing external vendors or service providers.
• Previous experience in a global, cross-functional environment.