DirecciónDescription
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)
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 regulatory requirements.
Solid background in MS-Office suite and other IS tools.
What we offer in return
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
