Product Quality Manager, Medical Devices

Hace 5 días

Barcelona, Catalonia, España Galderma Jornada completa
Job Title: Product Quality Manager, Medical Devices

Location:
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. Tis 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. If you're looking for a role that combines technical expertise, cross-functional collaboration, and the opportunity to influence quality at a global level, we encourage you to apply.

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-approval changes.
• 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.
• Enable inspection readiness by maintaining appropriate documentation, traceability, and product knowledge throughout the product lifecycle.
• 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 PhD) in Life Sciences, Pharmaceutical Sciences, Engineering, or a related discipline, combined with in-depth knowledge of cGMP, MDR (EU) 2017/745, 21 CFR Part 820 GDP, ISO13485, ICH, and other relevant regulatory requirements governing sterile products/Medical Devices.
• 7+ Certification in Quality Management (e.g., ASQ Certified Quality Auditor) and/or Lean Six Sigma certification is considered an asset.
• Experience working in global lifecycle management and external partner oversight is highly preferred.
• Strong interpersonal skills, with the ability to collaborate effectively across functions and a willingness to take on new challenges.
• Full professional proficiency in English, both written and spoken, is required. Next Steps
• If your application is successful and

your profile
is a match, we will invite you for a first virtual conversation with the recruiter.
• The next step is a virtual conversation with the hiring manager.
• The final step is a panel conversation with the extended team. We look forward to reviewing your application.