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 integral scale.
This is an opportunity to impact multiple products and initiatives within a leading dermatology-focused organization.
Compensaciones / Beneficios • 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) ********, 21 CFR Part 820 GDP, ISO*****, 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 •

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