19 oct
|
Galderma
|
Barcelona
19 oct
Galderma
Barcelona
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 general 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.
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.
📌 Product Quality Manager, Medical Devices (Barcelona)
🏢 Galderma
📍 Barcelona