Our client, a global pharmaceutical organization, is looking for an Impact Quality Lead to implement and maintain a balanced, proactive approach to pharmacovigilance compliance. This role provides leadership across post-marketing programs and ensures that all safety activities meet international regulatory standards and industry best practices.
Maintain global quality oversight of the pharmacovigilance system and the pharmacovigilance quality management system.
Provide expert guidance on GVP and GCP regulatory expectations, including FDA, EMA, and ICH standards.
Oversee patient-centric initiatives and phase IV studies, ensuring data integrity during signal detection and risk management.
Lead and host GVP audits and health authority inspections, managing remediation plans and audit findings.
Manage vendor and partner compliance through the monitoring of KPIs, metrics, and quality control checks.
Drive deviation management processes, including root cause analysis, CAPA implementation, and effectiveness evaluations.
Ensure the quality and compliance of safety outputs such as ICSRs, DSURs, RMPs, and REMS .
You have a Bachelor's degree in Life Sciences, Science, or Engineering.
You bring 8+ years of experience in GVP quality assurance, GVP auditing, or pharmacovigilance within the biotech or pharmaceutical industry.
You possess expert knowledge of global regulatory requirements including GVPs, GCP, FDA, MHRA, and ICH guidelines.
You have experience managing quality assurance systems, including CAPA, deviation management, and audit processes.
You're able to lead process improvement initiatives and work effectively within international, transversal environments.
You have strong analytical and conceptual skills with a high attention to detail.
You are fluent in English .
Nice to Have
Master's degree in a scientific discipline.
Experience with Veeva Systems and the Argus global safety database.
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