Product Quality Manager, Medical Devices

About the role

Galderma is opening a new Global Capability Center in Barcelona's Eixample district to support its global commercial and functional teams. As Product Quality Manager, Medical Devices, you join the Global Product Quality Team and shape quality across a portfolio of medical device and combination products. You work across the entire product lifecycle, from development and technical transfer to commercialization and post-launch, ensuring products meet the highest quality and regulatory standards.

Key responsibilities

• Drive quality oversight for assigned products and projects across development and lifecycle management.
• Contribute to product development, technical transfers, process validation, method transfers and post-approval changes.
• Review quality documentation, including design control documentation, technical transfer protocols, reports, risk assessments and related records.
• Support oversight of external manufacturing sites, laboratories and business partners, and contribute to regulatory and CMC documentation reviews.
• Maintain documentation, traceability and product knowledge to enable inspection readiness.
• Take part in quality risk assessments, investigations, CAPAs and resolution of quality issues.
• Deliver on time, support continuous improvement and follow quality systems and regulatory requirements.
• Provide quality input and recommendations, lead assigned quality activities or workstreams and prepare quality assessments for governance decisions.

Required profile

• Advanced degree (Master's or PhD) in Life Sciences, Pharmaceutical Sciences, Engineering or a related discipline.
• In-depth knowledge of cGMP, MDR (EU) 2017/745, 21 CFR Part 820, GDP, ISO 13485, ICH and other regulatory requirements for sterile products and medical devices.
• 7+ certification in Quality Management (e.g., ASQ Certified Quality Auditor) and/or Lean Six Sigma certification is an asset.
• Experience in global lifecycle management and external partner oversight is highly preferred.
• Strong interpersonal skills and full professional proficiency in English, written and spoken.