Impact Quality Lead – Pharmacovigilance (Bulle, Switzerland)

About the role

The Impact Quality Lead joins UCB’s R&D and Pharmacovigilance Quality team in Bulle, Switzerland. This global position is responsible for implementing a proactive, balanced approach to pharmacovigilance compliance and ensuring that all PV activities meet worldwide regulatory standards.

Key responsibilities

• Provide expert guidance on Good Pharmacovigilance Practices (GVP) and Good Clinical Practice (GCP) across FDA, EMA, ICH and other regulations.
• Oversee pharmacovigilance system and quality system, including Phase IV studies, post‑marketing commitments, and patient‑centric initiatives.
• Develop, review and maintain PV SOPs, work instructions and training materials.
• Manage vendor oversight, contract compliance, and audit/inspection readiness.
• Lead deviation, root‑cause analysis, CAPA implementation and risk‑mitigation activities.

Required profile

• Bachelor’s degree in Science, Engineering or related field.
• 12+ years of experience in GVP quality assurance, pharmacovigilance or related pharmaceutical/biotech roles.
• Fluent English (additional languages a plus).
• Proven experience leading GVP audits, regulatory inspections and supporting quality management systems.
• Strong analytical, problem‑solving and decision‑making abilities.

Required skills

• Good Pharmacovigilance Practices (GVP)
• Good Clinical Practice (GCP)
• Regulatory compliance (FDA, EMA, ICH)
• PV electronic systems
• SOP development and training