Inspection Management Quality Lead
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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.
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