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Impact quality lead

Braine-l'Alleud
Randstad Interim
Publiée le Publiée il y a 22 h
Description de l'offre

PpJoin our client in Braine-l'Alleud as a Global Pharmacovigilance quality lead to champion excellence in global healthcare quality systems through strategic leadership and hybrid collaboration. This role offers the chance to drive a culture of shared accountability while ensuring compliance across life-changing research and development processes. You will balance operational output with regulatory requirements to deliver sustainable access for patients worldwide. /p h3Key Responsibilities /h3 ul libStrategic PV Leadership : /b lead medium to high complexity projects to ensure the effectiveness of global Pharmacovigilance Quality Management Systems (QMS). /li libRegulatory Expertise /b : deliver expert guidance on Global Pharmacovigilance Practices (GVP) and GCP regulatory expectations (FDA, EMA, ICH) and industry best practices. /li libInspection Management : /b lead the hosting of PV audits and Health Authority inspections, developing and implementing effective remediation plans for findings. /li libCompliance Monitoring : /b oversee the on-time delivery of critical PV outputs, including ICSSrs, aggregate reports (DSURs), Risk Management Plans (RMPs), and REMS. /li libVendor Partner Oversight : /b ensure quality oversight and data integrity for PV activities delegated to external vendors and partners. /li libRisk Deviation Management : /b initiate deviations, conduct root cause analysis, and track the effectiveness of CAPA implementation. /li /ul h3Qualifications /h3 ul liYou bring 8 to 10 years of specialized experience bin drug safety/pharmacovigilance quality assurance within the pharmaceutical industry. /b /li liYou possess a deep understanding of quality management systems within an international and transversal environment. /li liYour background includes a strong internal and external network related to GCP and GVP standards. /li liYou demonstrate excellent verbal and written communication skills in English to engage with global stakeholders. /li liYour professional experience shows a proven ability to lead complex projects and influence organizational quality culture. /li liExperience a modern hybrid work model that offers the perfect balance between office collaboration and home-based focus. /li liContribute to a mission-driven organization dedicated to delivering innovative solutions and sustainable patient access. /li liWork a full-time schedule of 40 hours per week within a professional and approachable team environment. /li /ul pbReady to make a global impact on healthcare quality? We are looking forward to meeting you, so take the next step in your career and apply today! /b /p /p #J-18808-Ljbffr

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