Clinilabs
51 - 200 employees
Founded 2000
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Clinilabs is a global, full-service Contract Research Organization (CRO) specializing in the development of central nervous system (CNS) drugs, devices, and technology. The company provides comprehensive services to pharmaceutical, biotechnology, and medtech organizations, supporting their projects from first-in-human to Phase 3 clinical trials. Clinilabs is dedicated to addressing the significant unmet needs in CNS drug development, focusing on neurological, mental health, and substance use disorders.
Vice President – Quality Assurance
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Clinilabs
51 - 200 employees
Founded 2000
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Clinilabs is a global, full-service Contract Research Organization (CRO) specializing in the development of central nervous system (CNS) drugs, devices, and technology. The company provides comprehensive services to pharmaceutical, biotechnology, and medtech organizations, supporting their projects from first-in-human to Phase 3 clinical trials. Clinilabs is dedicated to addressing the significant unmet needs in CNS drug development, focusing on neurological, mental health, and substance use disorders.
📋 Description
• Provide leadership and direction to a growing quality and regulatory department • Manage quality-system organizational capability development, succession planning, and performance standards • Define process and system strategy recommendations, compliance-driven standards, and harmonization boundaries • Set strategy for, implement, and maintain Clinilabs Quality Systems • Serve as a quality-systems subject matter expert and resource leader • Guide computer-system and software validation, particularly for GCP-regulated systems • Conduct internal and external audits in compliance with company SOPs • Provide feedback to the quality control group • Establish and maintain processes, standards, and procedures aligned with regulatory requirements • Interact with the FDA and other regulatory bodies • Conduct qualification audits of contractors and vendors • Provide leadership and guidance on quality agreements • Develop measures to monitor quality-system effectiveness • Identify quality issues and improvement areas • Monitor employee training and the training program • Oversee the controlled document management system • Conduct or oversee internal and external audits • Develop or monitor the vendor qualification program • Perform other duties as assigned
🎯 Requirements
• At least a Bachelor’s degree required; advanced degrees preferred • Minimum 15 years working within a GXP function • Minimum 10 years of leadership experience in quality and/or compliance • Proven experience leading FDA, MHRA, and other regulatory inspection readiness, inspection activities, and responses • Strong influencing, negotiation, and leadership-without-direct-line-authority experience • Ability to manage complexity and a diverse team • Excellent written and oral communication and interpersonal relationship skills • Excellent leadership, influencing, and collaboration skills • Experience in a regulated industry required • Ability to work and communicate in a cross-cultural environment • Previous experience driving performance results
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