Head of Global Quality System
hace 1 semana
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 System
Location: Barcelona
Job Description
As part of the Operations and Commerical Quality, this role will establish (for new entities), maintain and develop Galderma's Global Quality Management System ensuring that Galderma's Policies and procedure remain compliant with the relevant government regulations according to the product applicable classification : cGMP, GDP, ISO, cGMP, GDP, ISO, Medical Devices regulations or any other relevant regulations and guidance and guidance. This position will ensure that appropriate personnel are properly and efficiently trained as per requirements.
Key Responsibilities
The incumbent will manage Global Quality System topics for Galderma in collaboration with his/her manager on the following 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. Ensures the qualification status of these tools is kept current.
- 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). Ensures the qualification status of this tools is kept current.
- Establish, develop, and maintain in collaboration with relevant stakeholders and Managers the appropriate Quality KPIs, targets and reporting ensuring an ongoing monitoring of the quality processes performance.
- Develop, maintain and improve templates for Quality KPI Dashboards, Quality Management Reviews and participates in Global Quality Reviews (preparation and presentation as needed)
- Prepare, manage and maintain an annual audit program ensuring vendors oversight in the areas of cGMP, GDP, ISO, Medical Devices regulations. Ensure the attainment of the annual audit plan. Ensure the auditor qualification program while maintaining enough qualified auditors.
- 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 and guidance)
- 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 regulatory requirements.
- Medical Device applicable regulation (NF EN ISO 13485; CMDCAS; directive 93/42/EC; 21 CFR 820, ...).
- Solid background in MS-Office suite and other IS tools.
- You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
- You will receive a competitive compensation package with bonus structure and extended benefit package.
- You will be able to work in a hybrid work culture.
- You will participate in feedback Loops, during which a personalized career path will be established.
- You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take on accountability
- Send your CV in English.
- If your profile is a match, we will invite you for a first virtual conversation with Talent Acquisition.
- The next step is a virtual conversation with the hiring manager.
- The final step is a panel conversation with the extended team.
At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.
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