Clinical Quality Assurance Manager

Whether it's the unique breadth of our integrated offering that covers Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology products; or our commitment to recognizing and rewarding people for the contribution they make - working here isn't like anywhere else.

At Galderma, we actively give our teams reasons to believe in our 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.

Job Title: Senior Clinical Quality Assurance Manager

Location: Barcelona

As part of Galderma’s R&D Quality Assurance team, you will contribute to ensuring the quality and regulatory compliance of clinical development activities.

Working closely with clinical study teams and external partners, you will provide GCP expertise, oversee quality risks, conduct audits, and support the qualification of service providers.

You will also contribute to the continuous improvement of the clinical Quality Management System, support regulatory intelligence activities, and coordinate regulatory inspections to ensure ongoing compliance and inspection readiness across Galderma’s clinical development activities.

Main responsabilities

- Support the development of the R&D Quality Assurance strategy covering Galderma sponsored R&D projects and ensure its implementation in the framework of Clinical Development activities,
- Develop R&D Quality Assurance objectives dedicated to Clinical Development in line with this strategy and budget constraints.
- In collaboration with the Audit Program Manager, coordinate the development and implementation of the R&DQA/Innovation Quality audit program dedicated to Galderma sponsored clinical development projects/studies and qualification of GxP service providers,
- Conduct internal (documents, processes, systems) and external audits in line with effective audit programs,
- Assure the compliance of clinical development activities with the company outsourcing governance by evaluating the GCP impact of outsourced activities, defining and conducting appropriate qualification plans of GCP services providers,
- Act as R&D Quality Assurance/Innovation Quality representative of the clinical study teams providing GCP quality assurance/compliance expertise and assuring a proactive and reactive quality approach in the framework of Galderma sponsored clinical development projects/studies,
- Contribute to the development and optimization of the Quality Management System dedicated to Clinical Development by supporting the regular update/optimization of applicable controlled documents (Policies, Standard Operating Procedures, Work Instructions and Forms),
- Support regulatory intelligence activities ensuring the compliance of Galderma Clinical Development Quality System with effective regulations and guideline,
- Provide appropriate training ensuring the buy-in by R&D employees of the quality management system and corresponding regulations and guideline,
- Participate to the quality analyses of Galderma first priority projects to identify any compliance trend that would potentially jeopardize the admissibility of their results by Competent Authorities,
- Assure international inspection readiness of Galderma R&D activities and coordinate GCP regulatory inspections conducted by Competent Authorities world-wide,
- Represent R&D Quality Assurance at dedicated congresses and promote the image of the Company

Qualifications & Skills

- Ideally, a Master’s degree in Pharmacy, Life Sciences, or a related field.
- Significant experience in R&D and Quality Assurance, with extensive experience in R&D audits, regulatory inspections, and the development and implementation of Quality Management Systems.
- Confirmed expertise in Good Clinical Practice (GCP) and applicable regulatory requirements.
- Familiar with R&D IT environment, tools (Documentum platform, Trackwise, Trial Interactive….) and validation approach (GAMP, 21CFR part 11…)
- Strong commitment to quality and scientific excellence, with a collaborative mindset
- Fluency in written and spoken English

Our people make a difference

At Galderma, you’ll work with people who are like you – and people who are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos create the perfect environment for people to thrive and excel in what they do.