Product Quality Manager, Medical Devices

galderma

Barcelona

On-site

EUR 90,000 - 120,000

Full time

2 days ago
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Job summary

Galderma is seeking a Product Quality Manager for Medical Devices in Barcelona to lead quality oversight across the product lifecycle, from development to post‑launch. You will influence quality strategy globally, ensuring regulatory alignment and readiness across multiple products and partners.

You will drive inspection readiness, manage risk assessments, CAPAs, and support governance with robust documentation and cross‑functional collaboration.

Qualifications

  • Advanced degree in Life Sciences or related field with regulatory knowledge.
  • Strong understanding of quality systems and lifecycle management.
  • Experience with external partner oversight and regulatory reviews.
  • Familiarity with MDR, GMP, ISO13485 and related standards.

Responsibilities

  • Drive quality oversight for products across development and lifecycle management.
  • Contribute to product development, transfers, validation, and post‑approval changes.
  • Review quality docs, especially Design Control, transfer protocols, reports and risks.
  • Oversee external sites, labs, and partners; support regulatory/CMC reviews.
  • Ensure inspection readiness with proper documentation and traceability.
  • Lead quality risk assessments, CAPAs, and issue resolution.
  • Deliver on assigned tasks; support continuous improvement within quality systems.
  • Provide input, lead activities, and assist governance decision documentation.

Skills

cGMP knowledge
EU MDR knowledge
ISO13485 knowledge
Quality management
Lean Six Sigma
Partner oversight

Education

Advanced degree in Life Sciences

Job description

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. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

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 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. 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‑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 professiona
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