With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries.
We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, 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.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, Galderma's 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:Head of Global Quality SystemLocation:BarcelonaJob Description:As part of the Operations and Commercial Quality, this role will establish (for new entities), maintain and develop Galderma's Global Quality Management System ensuring that Galderma's Policies and procedures remain compliant with the relevant government regulations according to the product applicable classification: cGMP, GDP, ISO, Medical Devices regulations or any other relevant regulations and guidance.This position will ensure that appropriate personnel are properly and efficiently trained as per requirements.Key Responsibilities:Manage with the relevant stakeholders, the creation and revision of the Global Documents (including Quality Policies, Global SOPs, and Guidelines, etc.)
which support an end-to-end management of the quality processes.Establish (for new entities), maintain, and develop Galderma's global Quality Management System through the electronic Quality Management System (eQMS) and the electronic Document Management System (eDMS) while ensuring compliance with the government regulations.Establish, develop, and maintain in collaboration with relevant stakeholders and Managers the appropriate training plans for the teams using our global Learning Management System (gLMS).Establish, develop, and maintain in collaboration with relevant stakeholders and Managers the appropriate Quality KPIs, targets and reporting ensuring ongoing monitoring of the quality processes performance.Develop, maintain and improve templates for Quality KPI Dashboards, Quality Management Reviews and participate in Global Quality Reviews (preparation and presentation as needed).Prepare, manage and maintain an annual audit program ensuring vendor oversight in the areas of cGMP, GDP, ISO, Medical Devices regulations.
Ensure the attainment of the annual audit plan.Ensure a regulatory surveillance of the evolution of the applicable government regulations (including cGMP, GDP, ISO, Medical Devices regulations or any other relevant regulations and guidance).Skills Qualifications:Background in Medical Device, pharmaceutical or biopharmaceutical industry.A demonstrated knowledge and execution of Quality System Management.Knowledge of electronic training management systems.Knowledge of different regulations:Medical Device applicable regulation (NF EN ISO 13485; CMDCAS; directive 93/42/EC; 21 CFR 820).GMP (FDA, EU, ICH, PICs regulations, cGMPs related to all major territories).GDP regulations.
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