Quality Head

Veeda Lifesciences is seeking a Quality Head based in Europe for its growing international hematology/oncology Clinical Trials program. This is a full-time job. Job overview:Quality Head is to provide comprehensive leadership in establishing and maintaining a robust quality management system that ensures compliance with regulatory requirements, relevant local and international standards, and sponsor guidelines, which aims to enhance the quality of clinical trials worldwide, promote continuous improvement, and cultivate a culture of quality excellence that supports the organization’s strategic objectives and enhances customer satisfaction. Main responsibilities:Develop and execute a global Quality Assurance strategy aligned with business objectives, regulatory expectations, and organizational goals.Establish, maintain, and continuously improve the Quality Management System (QMS) to ensure consistent quality standards across clinical operations.Partner with cross-functional and regional leaders to embed a strong quality culture and ensure effective implementation of quality practices across the organization.Define, monitor, and analyze quality metrics and KPIs to assess operational performance, identify risks, and drive data-driven quality improvements.Ensure compliance with ICH-GCP, local and international regulations, sponsor requirements, internal SOPs, and applicable quality standards.Lead quality oversight activities, including co-monitoring visits, management reviews, quality assessments, and initiatives to enhance clinical trial quality and compliance.Manage internal audit programs, including system audits, investigator site audits, and vendor/supplier audits, while ensuring inspection readiness for clients and regulatory authorities.Oversee quality issue management, CAPA processes, deviation investigations, and corrective actions to prevent recurrence of compliance issues.Develop and maintain quality policies, SOPs, and processes while driving risk-based quality management and continuous improvement initiatives.Lead, mentor, and develop a high-performing quality team through effective coaching, talent development, performance management, and succession planning. Job Requirements:Master’s degree in Life Sciences, Pharmacy, Medicine, Biotechnology, or a related health sciences discipline, with relevant quality and clinical research certifications.Professional certifications in quality and clinical standards such as ISO 9001 Lead Auditor, ICH-GCP, ISO 13485 (advantage), and Lean/Six Sigma methodologies are preferred.Minimum 15 years of experience in the CRO/pharmaceutical clinical research industry, including at least 7-10 years in senior Clinical Quality Assurance leadership roles within a CRO. Extensive experience with ICH-GCP, EU Clinical Trial Regulation (EU 536/2014), CTIS, regulatory inspections (EMA, MHRA, FDA), vendor quality management, CAPA systems, and quality oversight of multinational Phase III and Phase IV clinical trials.Proven expertise in designing, implementing, and maintaining Quality Management Systems (QMS) and ensuring compliance with global quality standards.Strong knowledge of clinical trial regulations, ICH-GCP, FDA, EMA, MHRA, local regulatory requirements, and sponsor expectations.Extensive experience in Clinical Quality Assurance activities, including regulatory inspections, internal and external audits, vendor qualification, and inspection readiness.Demonstrated expertise in risk-based quality management (RBQM), CAPA management, root cause analysis, deviation management, and continuous improvement practices.Strong understanding of ISO standards, quality metrics, KPI development, quality reporting, and process improvement methodologies such as Lean and Six Sigma.Proven ability to lead global or multi-country quality operations, influence senior stakeholders, manage change, and drive strategic quality initiatives.Exceptional leadership, communication, collaboration, coaching, problem-solving, and team development skills with a strong focus on customer satisfaction and operational excellence. Join us to be part of a multidisciplinary team of highly skilled scientists and healthcare professionals in the forefront of Clinical Research within a friendly work environment.