28 oct
|
Galderma
|
Barcelona
28 oct
Galderma
Barcelona
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries.
We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology.
At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world.
Further supporting our growth and innovation momentum, we are establishing a new Global Capability Center in Barcelona to deploy new capabilities to effectively support its global commercial and functional teams.
Located in the upscale Eixample District in the heart of Barcelona, Galderma's Global Capability Center offers numerous possibilities for professional development such as exposure to global and cross?functional projects and access to global career opportunities.
Job Title: Product Quality Manager, Medical DevicesLocation: Barcelona, Spain Join Galderma's Global Product Quality Team and play a key role in shaping quality across a portfolio of medical device and combination products.
Working across the entire product lifecycle, from development and technical transfer to commercialization and post?launch activities, you will help ensure products meet the highest quality and regulatory standards while supporting successful delivery of key business objectives.
As a visible partner to global teams, you will provide quality guidance, drive inspection readiness and compliance, and help strengthen the global governance framework.
This is an opportunity to act as a trusted advisor, influence quality strategy on a global scale,
and make a meaningful impact across multiple products, projects, and stakeholders.
Key Responsibilities Drive quality oversight for assigned products and projects across development and lifecycle management activities.
Contribute to product development, technical transfers, process validation, method transfers, and post?Review and assess quality documentation, with a focus on Design Control Documentation, technical transfer protocols, reports, risk assessments, and related records.
Support quality oversight of external manufacturing sites, laboratories, and business partners, and contribute to regulatory and CMC documentation reviews as applicable.
Engage in quality risk assessments, investigations, CAPAs, and resolution of quality issues.
Direct timely completion of assigned deliverables, contribute to continuous improvement initiatives, and perform activities in accordance with applicable quality systems, regulatory requirements, and governance processes.
Provide quality input and recommendations, lead assigned quality activities or workstreams as delegated, and support the preparation of quality assessments and documentation for governance decisions.
Skills & Qualifications Advanced degree (Master's or Ph D) in Life Sciences, Pharmaceutical Sciences, Engineering, or a related discipline, combined with in-depth knowledge of c GMP, MDR (EU) ********, 21 CFR Part 820 GDP, ISO*****, ICH, and other relevant regulatory requirements governing sterile products/Medical Devices.
7+ Certification in Quality Management (e.ASQ Certified Quality Auditor) and/or Lean Six Sigma certification is considered an asset.
Experience working in integral lifecycle management and external partner oversight is highly preferred.
📌 Product Quality Manager, Medical Devices (Barcelona)
🏢 Galderma
📍 Barcelona