Product Quality Manager, Medical Devices

Galderma Laboratories, LP; Barcelona; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

Galderma Laboratories, LP seeks a Product Quality Manager, Medical Devices in Barcelona. Hybrid work model (4 days on-site) supporting a global product quality team across development, transfer, and post-launch activities.

The role emphasizes MDR/EU and ISO13485 compliance, cGMP standards, and external partner oversight. Fluent English and advanced degrees are required for cross-functional collaboration and regulatory interactions.

Qualifications

• Advanced degree plus in-depth knowledge of regulatory requirements governing sterile Medical Devices.
• Experience with global lifecycle management and external partner oversight is preferred.
• Strong written and spoken English required with ability to interact across functions.

Responsibilities

• Drive quality oversight for assigned medical device products across development and lifecycle.
• Support regulatory and CMC documentation reviews and inspection readiness.
• Contribute to design controls, risk assessments, and post-approval changes.
• Collaborate with internal teams and external partners to ensure compliance and governance.

Skills

Quality management

Regulatory knowledge

cGMP

ISO13485

MDR 2017/745

English proficiency

Cross-functional

Quality systems

Inspection readiness

Stakeholder engagement

Education

Master's or PhD in Life Sciences/Pharmaceutical Sciences/Engineering

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

Work Model: Hybrid (4 days on-site)

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 professional proficiency in English, both written and spoken, is required.