Experteer Overview
In this role, you will drive quality oversight for medical devices across development and lifecycle management within a global framework. You will partner with cross-functional teams to ensure regulatory and quality standards are met throughout development, transfer, and post-launch activities. Your work supports external manufacturing partners and governance processes, influencing quality strategy at a global scale. This is an opportunity to impact multiple products and initiatives within a leading dermatology-focused organization.

Compensaciones / Ventajas
• Drive quality oversight for assigned products and projects across development and lifecycle management activities
• Contribute to product development, transfers, process validation, and post-approval changes
• Review quality documentation focusing on Design Control, transfer protocols, risk assessments, and reports
• Support quality oversight of external manufacturing sites, labs, and partners; contribute to regulatory and CMC documentation reviews
• Enable inspection readiness by maintaining documentation, traceability, and product knowledge




• Engage in quality risk assessments, investigations, CAPAs, and issue resolution
• Direct timely completion of deliverables and contribute to continuous improvement within quality systems and governance
• Provide quality input and recommendations, lead quality activities or workstreams as delegated and support governance documentation

Responsabilidades
• Advanced degree (Master or PhD) in Life Sciences, Pharmaceutical Sciences, Engineering, or related discipline
• In-depth knowledge of cGMP, MDR (EU) 2017/745, 21 CFR Part 820 GDP, ISO13485, ICH and related regulatory requirements for sterile products/Medical Devices
• 7+ years of work experience in quality management or related field
• Experience with global lifecycle management and external partner oversight is highly preferred
• Strong interpersonal and cross-functional collaboration skills
• Full professional proficiency in English (written and spoken)

Requisitos principales
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📌 Product Quality Manager, Medical Devices (Barcelona)
🏢 Galderma
📍 Barcelona