Clinical Quality Assurance Manager

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 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.

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 be like you - and people that? Tol ... .