Senior Clinical Quality Assurance Leader (GCP & Audits)

Galderma; Paris; On-site; EUR 85,000 - 110,000; Full time

Job summary

Galderma seeks a Senior Clinical Quality Assurance Manager in Barcelona to ensure quality and regulatory compliance of clinical development activities. You will work with clinical study teams and external partners providing GCP expertise, overseeing quality risks, audits, and qualification of service providers.

You will contribute to the QMS, support regulatory intelligence, coordinate inspections worldwide, and train R&D staff on the quality framework.

Qualifications

• Extensive experience in R&D and QA with audits and regulatory inspections.
• Experience in developing and implementing Quality Management Systems.
• GCP expertise and knowledge of applicable regulatory requirements.
• Familiar with R&D IT tools and validation approaches (GAMP, 21 CFR Part 11).
• Strong commitment to quality and scientific excellence, with a collaborative mindset.
• Fluency in written and spoken English.

Responsibilities

• Support R&D QA strategy development for Galderma sponsored projects.
• Coordinate audits and qualification of GxP service providers.
• Ensure compliance with outsourcing governance and GCP impact assessments.
• Represent QA on clinical study teams and ensure proactive quality.
• Support regulatory intelligence activities and inspection readiness.
• Contribute to the Quality Management System improvement.
• Provide training on QMS and regulatory guidelines.
• Coordinate regulatory inspections worldwide.
• Promote the company's image at congresses.

Skills

GCP expertise

Audits (R&D)

Quality Management Systems

Regulatory inspections

English fluency

R&D IT tools (Documentum, Trackwise, T

Education

Master's degree in Pharmacy, Life Sciences, or a related field

Tools

Documentum

Trackwise

Trial Interactive

Job description

Galderma seeks a Senior Clinical Quality Assurance Manager in Barcelona to ensure quality and regulatory compliance of clinical development activities. You will work with clinical study teams and external partners providing GCP expertise, overseeing quality risks, audits, and qualification of service providers.

You will contribute to the QMS, support regulatory intelligence, coordinate inspections worldwide, and train R&D staff on the quality framework.