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 bodys 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 Galdermas 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 Galdermas 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.
If youre looking for a role that combines technical expertise cross-functional collaboration and the opportunity to influence quality at a integral 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 (Masters 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.
Required Experience:
Manager
📌 Product Quality Manager, Medical Devices (Barcelona)
🏢 Galderma
📍 Barcelona
Postulate a este anuncio
Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.