Senior R&D Quality Assurance Lead (GCP/Regulatory)

Galderma; Paris; On-site; EUR 70,000 - 100,000; Full time

Job summary

Galderma is seeking a Senior Clinical Quality Assurance Manager to join the R&D Quality Assurance team in Barcelona. You will contribute to ensuring quality and regulatory compliance of clinical development activities, working with clinical study teams and external partners to provide GCP expertise and oversee quality risks.

You will coordinate audits, support the qualification of service providers, and drive continuous improvement of the QMS for clinical development, including regulatory

Qualifications

• Master’s degree in Pharmacy, Life Sciences, or related field.
• Extensive R&D QA experience with audits and regulatory inspections.
• GCP expertise and regulatory knowledge.
• Familiar with R&D IT tools Documentum, TrackWise, Trial Interactive and validation (GAMP, 21 CFR 11).
• English language proficient, written and spoken.

Responsibilities

• Develop and implement the R&D QA strategy for Galderma's clinical development.
• Coordinate GCP audits and regulatory inspections globally.
• Ensure compliance with Quality Management System across Clinical Development.
• Provide training on quality management regulations to R&D staff.
• Support regulatory intelligence activities and inspection readiness.

Skills

R&D QA

GCP expertise

Audits

Regulatory inspections

Quality Management Systems

GAMP compliance

English fluency

Education

Master’s degree in Pharmacy, Life Sciences, or related field

Tools

Documentum

TrackWise

Trial Interactive

Job description

Galderma is seeking a Senior Clinical Quality Assurance Manager to join the R&D Quality Assurance team in Barcelona. You will contribute to ensuring quality and regulatory compliance of clinical development activities, working with clinical study teams and external partners to provide GCP expertise and oversee quality risks.

You will coordinate audits, support the qualification of service providers, and drive continuous improvement of the QMS for clinical development, including regulatory