Impact Quality Lead – Pharmacovigilance

About the role

UCB is seeking an Impact Quality Lead to join the Impact Quality team within RDPVQ. This global role ensures proactive, balanced pharmacovigilance (PV) compliance across all UCB activities, supporting patient‑centric initiatives and post‑marketing commitments.

Key responsibilities

• Provide expert guidance on Good Pharmacovigilance Practices (GVP), Good Clinical Practice (GCP) and global regulatory expectations (FDA, EMA, ICH) to ensure compliance and operational excellence.
• Oversee PV system validation, electronic system control, and the quality of outputs such as ICSR, DSUR, RMP and REMS.
• Develop, revise and train on PV SOPs, work instructions and ensure alignment with evolving regulations.
• Manage vendor oversight, monitor contract compliance, conduct audits and support inspections, delivering remediation plans as needed.
• Lead compliance monitoring, KPI tracking, deviation management, root‑cause analysis and CAPA implementation.

Required profile

• Bachelor’s degree in Science or Engineering (or equivalent).
• 12+ years of experience in GVP Quality Assurance, GVP auditing, pharmacovigilance or related fields within pharma/biotech.
• Fluent English communication (oral and written); additional languages are a plus.
• Proven experience leading GVP audits, regulatory inspections and supporting quality management systems.

Required skills

• Good Pharmacovigilance Practices (GVP) and Good Clinical Practice (GCP) expertise.
• In‑depth knowledge of FDA, EMA, ICH regulations.
• Pharmacovigilance system validation and electronic system oversight.
• SOP development, training delivery and regulatory alignment.
• Audit and inspection support, vendor oversight, risk management and CAPA processes.