Purpose of this function
To develop, document, implement and maintain the Quality Management System of the affiliate in compliance with the requirements defined by the division and the regulators in the Central America & The Caribbean’s region.
To support and guide the organization towards achieving excellence and continuous improvement of its internal processes, always having our regulators, our customers and specially our patient in the center for every decision.
Responsible for the adoption and implementation of processes in compliance with corporative, divisional and local regulatory requirements.
To act as local contact for Global Quality for sharing of information related to the local Quality Management. System.
To Support the organization to define, develop, implement, simplify and document (whenever it’s needed) processes within the organization to guarantee efficiency, product / service safety and compliance.
To support the organization in the definition and subsequent follow-up of Key Performance Indicators that helps the Leadership Team to understand and take measurements over the processes performance.
To serve as primary affiliate contact for product safety related matters, acting as Local Safety Officer or Deputy.
Ensures compliance to Global Quality Guidelines and Recommendations in terms of quality and safety of products Responsible for prompt execution of activities in regards with product notifications.
To Serve as primary contact for local regulatory authorities related to complaints, recalls and / or corrective field actions.
In alliance with the 3rd Parties (Distribuitors & 3PL’s), ensures the definition and implementation of the appropriate Quality Assurance practices in order to guarantee product safety through the whole Supply Chain process under the affiliate’s responsibility.
This includes temperature-monitoring processes.
Represents the local organization in regional and divisional working groups in order to share the affiliate’s experiences, business characteristics and defend our local specific agenda / interests.
Defines and leads local training programs about topics under his / her responsibility. Defines and executes the yearly distribuitor’s selection and follow-up audit plan.
Manages and prepares the organization for the visits, inspections and / or audits that has the quality management system processes under its scope.
University Degree on Healthcare, Engineering or similar.
With knowledge and working experience on quality management systems and process improvement tools and methodologies.
Preferable with Experience preparing, performing, reporting and following Audits
Preferable with knowledge and experience in agile methodologies.
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups.
Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.