• Leading Supply Chain Manager, Operations (logistics) Manager and Quality Coordinator to ensure the whole operations for PHIBRO México and CAM.• Responsible of the Quality System in order to maintain compliance with the certified standards such as ISO 9001:2015, SQF, SOx and local regulations.• Receiving and coordinating external audits to comply with the regulations and certification requirements.• Creating and controlling Budget for internal processes and operational expenses.• Responsible for product logistics and Customer Service.• Responsible for supply chain, purchasing program and manufacturing planning.• Leading the restructure of the supplier management system in order to improve the selection, assessment and monitoring of suppliers based on risk. Introducing the ASL (Approved Suppliers List)• Leading the implementation of alternate suppliers program.• Responsibile of developing critical suppliers for CMO activities.• Leading process improvement projects across supply chain, logistics and quality in order to obtain hard savings and process efficiency.• Strategic decision making and conflict resolution derived from the systems under my charge.• Participation in meetings with the top management in order to communicate projects status and relevant information of the systems.

• Restructure of the quality system to meet the requirements for ISO 9000:2015 certification program.• Reestructure of the food safety system to meet the requirements for SQF certification program. • Responsible for receiving and coordinating the logistic for customer’s audits and regulatory inspections.• Coaching of personnel how to behave and handle an external audit.• Active participation in audits. Interaction with external auditors and consultants.• Defining, implementing, and improving the site KPIs and quality indicators.• Leading and coordintate Management Review Meeting.• Responsible for the internal audit program.• Review and approval of validation protocols for pharmaceutical processes.• Responsible of Raw material release for product manufacturing.• Responsible of product release for market distribution.• Review and approval of manufacturing master documents.• Lead of the GFSI-SQF and HACCP implementation for food safety.• Strategic decision making and conflict resolution derived from the systems under my charge.• Participation in meetings with the top management in order to communicate projects status and relevant information of the systems.

• Knowledge of the regulations related to Drugs and Medical Devices distributed in Mexico: NOM-059, NOM-241, NOM-073, and NOM-072. • Knowledge of the regulations related to Drugs and Medical Devices distributed in international markets: ISO 13485, US. 21 CFR 210, 211 y 820. Health Canada C.R.C, c. 870 part C Drugs / GUI-0001 “GMP guide for drug products”.• Knowledge of the regulations related to beverages (food) distributed in the US: 21 CFR 117 (FSMA), 21 CFR 110, and SQF code.• Responsible for receiving and coordinating the logistic for customer’s audits and regulatory inspections.• Coaching of personnel how to behave and handle an external audit.• Active participation in audits. Interaction with external auditors and consultants.• Defining, implementing, and improving the site KPIs and quality indicators.• Review and approval of validation protocols for pharmaceutical processes.• Responsible of Raw material release for product manufacturing.• Responsible of product release for market distribution.• Review and approval of manufacturing master documents.• Responsible of Annual Product Review (APR).• Lead of the GFSI-SQF and HACCP implementation for food safety of beverages distributed in the US market.• Member of the quality council for the implementation of relevant project for the company.• Strategic decision making and conflict resolution derived from the systems under my charge.• Participation in meetings with the top management in order to communicate projects status and relevant information of the systems.

• Maintain the regulatory compliance of the manufacturing site through the audit program and quality system management. • Lead auditor with overseas experience. Auditing company facilities and suppliers across the US. Full English audits.• Knowledge of the regulations related to Drugs and Medical Devices distributed in Mexico: NOM-059, NOM-241, NOM-073, and NOM-072. • Knowledge of the regulations related to Drugs and Medical Devices distributed in international markets: ISO 13485, US. 21 CFR 210, 211 y 820. Health Canada C.R.C, c. 870 part C Drugs / GUI-0001 “GMP guide for drug products”.• Health Canada C.R.C, c. 870 part C Drugs / GUI-0001 “GMP guide for drug products”.• Responsible for receiving and coordinating the logistic for customer’s audits and regulatory inspections such as FDA and COFEPRIS. Coaching of personnel how to behave and handle an external audit.• Active participation in audits. Interaction with external auditors and team member of internal audit program.• Quality System implementation for new products development. • Project leader for the implementation of ISO 13485:2016. Use of tools to evaluate the current quality system against the new regulatory requirements.• Project leader for the restructuration of site Quality Manual (harmonization corporate project).• Fresenius Guadalajara representative for the harmonization of saving projects with other manufacturing plants in North America (plants Knoxville, Tennessee and Ogden, Utah).• Coordinate the Quality System Management Review.• Implementing the Risk Management System and FMEA for new products.• Responsible of customer complaints management system. • Responsible of suppliers management system, focus to quality.• Responsible of personnel training system, focus to quality.• Responsible of product release for market distribution.• In charge of keeping the product up to par to the required specifications, Master Manufacturing Files and product design.

• Implementation of suppliers certification (20K USD savings per year). Reduction of in-coming materials testing through statistical analysis. Testing optimization.• Project leader for the implementation of alternate suppliers (25K USD savings per year).• Conduct on-site audits for critical suppliers. • Manage effective supplier corrective actions for non-conformances and audit findings.• Work in conjunction with North American corporate for the restructure of the suppliers management system. • Evaluation and selection of qualified suppliers.

• Management and solving problems related to non-conformances system.• Root cause analysis techniques. Use of statistics and quality tools. Creation of technical reports. • Coordinating and assembling of work groups for solving problems.• Management of change control system. • Knowledge of the risk management system (creation of risk assessments) and CAPA system (corrective and preventive actions). • Elaboration of the product annual report.

• Coordinating stability annual program for drugs and medical devices. Creation of stability studies protocols and conducting lab testing for stability samples. Handling of laboratory equipment for chemical analysis to product.• Review of Manufacturing Master Files.• Creation of control limits (UCL and LCL) for product based in the statistical tools. • Qualification of laboratory equipment (IQ y OQ) and validation-revalidation of analytical methodology.