Benjamin Rodriguez Romo

Experience

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  Novartis

  Jun 2013 - Jul 2018

  - Implement, control and maintain Quality Systems according to GxP, global, local and corporate regulations.- Follow up to Complaints (AQWA). Main QA contact for Pharmacovigilance and Medical Information.- SPOC for all Novartis MFG sites related to product complaints and product quality issues.- Coordinate the implementation of new Quality Manual modules, directives, new local, corporate and global regulations; management of GAP assessments, implementation projects and procedures update and creation. - Coordinate the Escalation process for major GxP incidents to Regional, and Global QA Group team.- Coordination of Quality Risk Assessments for issues with potential impact to product quality, patient safety and to the business (Commercial, Supply Chain, etc.). Show less

  • Quality Systems Coordinator

    May 2015 - Jul 2018

  • QA Projects Trainee

    Jun 2013 - May 2015
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  Galderma

  Jul 2018 - May 2021

  - Lead and coordinate activities related to Quality Assurance in Galderma Mexico Affiliate & CADR Region.- Maintain the local Quality Management System and monitor its compliance status. Responsible for ensuring regulatory compliance in all applicable GxP regulation in Galderma QA Organization and Warehouse operations.- Designated as Affiliate Qualified Person (QP) and Local Safety Officer (LSO) before Local Health Authority.- Support Mexico and CARD Regional organization to assure compliance to local, regional, global and corporate regulations, and appropriate implementation of responsibilities and processes related to Quality and PV.- Disseminate the Quality Culture through all Galderma Mexico Organization.- Manage local budget related to Quality and Pharmacovigilance operations.- Develop and manage effective working relationships with local HA, LATAM Region & Global Quality functions. Foster and maintain good cross-functional working relationships with other departments as Quality leader.- Contribute to the correct use of Galderma’s image based on Corporate and local policies. Show less - Maintain local Quality Management System and monitor its compliance status.- SPOC for LATAM and Global QA Organizations related to QA Incidents and GxP projects for implementation.- Support to Regulatory & Medical Affairs for HCP Compliance and Medical Affairs policies implementation in LAS.- Implement, maintain and ensure execution of Self Inspection Annual Plan and Audit readiness.- Implement and maintain Quality (TQA) and Safety (PV) Agreements for Third Parties.- Local Safety Officer (LSO) to ensure adequate implementation and compliance of PV & TV Systems.- Manage and maintenance of Sanitary Import Licenses for all Galderma products. Show less

  • Qualified Person & Local Safety Officer (QP & LSO)/ Mexico & CARD Region

    Jun 2020 - May 2021

  • Quality & Pharmacovigilance Specialist (LSO)/ Mexico & CARD Region

    Jul 2018 - Jun 2020
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  Novartis

  May 2021 - now

  Associate Director - Global GxP/Quality Incidents Management

  − Manage GxP/Quality Incidents in an end-to-end process that require cross-functional guidance and coordinationas well as alignment on global level to achieve consistent cross-functional decisions across multiple sites, entitiesand countries.− Support and arrange Health Authority communication on a global level.− Support the definition and drive the implementation of corrective and preventive measures related to GxP/Qualityincidents on global level, including market actions, if required.− Facilitate creation of knowledge repositories and roll out of lessons learned; facilitate the maintenance of globalincident management processes and procedures.− Collaborate across functions in resolving GxP/Quality Incidents and preventing recurrence.− Support related GxP/Quality incident prevention activities across the entire organization. Show less