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Quality Maintenance Manager

  • Distans
  • Sverige
  • Engelska
  • Publicerad 02.09.26 11:19

Veeda Lifesciences is seeking a Quality Maintenance Manager based in Europe for its growing international hematology/oncology Clinical Trials program. This is a full-time job. Job overview:Quality Maintenance Manager is to lead development, implementation and, maintenance of the Company’s Quality Management System (QMS) in compliance with applicable standards and regulations, conduct effective training, support audits and inspections, analyze non-conformance trends, and contribute to client satisfaction initiatives to uphold high standards in clinical operation while fostering a culture of quality throughout the organization. Main responsibilities:Develop, implement, maintain, and continuously improve the company's Quality Management System (QMS) in compliance with applicable regulations, industry standards, GCP, and data protection legislation.Collaborate with cross-functional teams to develop, review, and maintain quality documentation while promoting quality principles across all business processes.Plan, deliver, and evaluate quality training programs, ensuring employees and subcontractors are adequately trained on QMS requirements.Coordinate quality risk management, change management, deviations, CAPAs, complaints, and quality performance monitoring to support continuous improvement.Support client audits, regulatory inspections, certification audits, and due diligence activities, ensuring compliance with applicable regulations and quality standards.Provide guidance on quality regulations, GCP, and industry requirements while coordinating responses to audit findings and recommendations.Ensure compliance with company policies, SOPs, QMS, ISMS, study protocols, sponsor requirements, and applicable national and international regulations.Contribute to the continuous improvement of quality systems, processes, and organizational performance through monitoring, analysis, and implementation of best practices. Job Requirements:Bachelor's degree in Natural or Health Sciences, Pharmacy, Life Sciences, or a related field.Certification or training in Quality Assurance or Quality Management Systems is an advantage.6–7 years of experience in Quality Management Systems (QMS) within a Clinical Research Organization (CRO).Experience supporting audits and regulatory inspections across various global sites.Good knowledge of Quality Management Systems, clinical trial regulations, and ICH-GCP.Experience in audit support, process improvement, training, and documentation management.Strong communication, collaboration, analytical, and problem-solving skills.Excellent organizational skills, attention to detail, and commitment to quality and continuous improvement. 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