**Date:** Dec 15, 2025 **Address:** Carr. a San Isidro Mazatepec 7, JALISCO, MX **Company:** Grupo PiSA Live your purpose and make a difference with Grupo PiSA. With over 80 years of history, Grupo PiSA is a 100% Mexican company committed to the health and well-being of millions of people, both in Mexico and internationally. Our growth reflects the effort, passion, and dedication of a team focused on excellence. Join us and become part of a company where every day is an opportunity to live "A Life in Service of Life." Together, we can transform the future of healthcare and leave a positive mark on the world!**Type of Employee** Trust-based employee**Job Objective** Ensure that activities related to procurement, manufacturing, packaging, analysis, validation, storage, and distribution of products are conducted in accordance with the Quality Management System and regulatory requirements (COFEPRIS, FDA, INVIMA, ISO 9001), maintaining the validated status of equipment, processes, and methodologies, and managing departmental resources for continuous improvement of the system.**Responsibilities and Activities** *Guarantee product quality throughout manufacturing and the supply chain.* 1.1 Ensure compliance with current health regulations, GMP/GLP and SOPs across all site activities. 1.2 Stay updated on GMP, GDP, GLP, and applicable regulatory requirements. *Implement, maintain, and improve the Quality Management System (QMS) in accordance with regulations and internal policies.* 2.1 Review and approve site SOPs, ensuring alignment with current health regulations and internal procedures. 2.2 Ensure that Master Manufacturing Orders, bills of materials, and manufacturing/packaging instructions comply with authorized registration conditions and that only current versions are used. *Ensure achievement of quality objectives and efficient resource management.* 3.1 Consistently meet KPIs, quality indicators, and objectives; identify risks and action plans to achieve them. 3.2 Prepare technical reports and executive presentations for senior management. *Guarantee regulatory-compliant handling of controlled materials.* 4.1 Ensure forecasting for raw materials, finished products, and controlled standards. 4.2 Coordinate requests and facilitate COFEPRIS unsealing inspections and usage authorizations. Experience a. Implementation and maintenance of quality systems in the pharmaceutical industry. b. Reception/management of inspections (COFEPRIS, FDA, INVIMA). c. Leadership, team integration, and team development. Knowledge a. Knowledge: NOM-059, NOM-073, NOM-177; 21 CFR (Parts 11, 210, 211) b. Budget management and control; continuous improvement tools (Lean in laboratory, Six Sigma). c. GLP; ICH, WHO, FEUM, USP. Education * Master’s degree preferred Bachelor’s degree in Chemical-Pharmaceutical or Chemical-Biological fields**Complementary Profile** a. Technical fundamentals of pharmaceutical manufacturing equipment and process operations; continuous improvement projects. b. HACCP systems; SQF and PCQI schemes; risk management. At Grupo PiSA, we prohibit violence and discrimination, promoting equal opportunity, inclusion, and diversity. Our selection processes are FREE OF CHARGE; report any irregularity to lineaeticagrupopisa@letica.email