Graciane Taglietti

•      Strategic direction of Grupo JMA, responsible for three business units and a portfolio of major pharmaceutical clients across Brazil and Mexico. •      Define the commercial, operational, and growth strategy of the group, leading expansion into new markets and the integration across all three units — JMA PLAN (engineering, quality, and validation), Âmirah Soluções (specialized professional outsourcing and workforce management), and JMA TI (technology and IT staffing). •      Lead the portfolio of engineering, qualification, and validation projects for the pharmaceutical industry, ensuring regulatory compliance (GMP/GxP, FDA, EMA, ANVISA, COFEPRIS, EU GMP) and delivery on time and on budget. •      Build and develop a technical team of 40+ professionals, focused on high performance and retention.

•      Founded JMA TI to integrate technology and specialized talent into the group's engineering and quality projects. •      Structure the specialized IT staffing offering and technology solutions for pharmaceutical and life sciences clients. •      Connect digital compliance (CSV, data integrity, 21 CFR Part 11) to technology delivery, creating direct synergy with JMA PLAN.

•      Led project risk assessment and business impact analysis for Novartis initiatives in Mexico. •      Managed end-to-end pharmaceutical projects, ensuring regulatory compliance and delivery on time and on budget. •      Led the Remediation Plan following the 2017 earthquake: transferred quality control operations to two third parties and reinstated 50% of operations in a leased facility in just 3 months, maintaining uninterrupted market supply. •      Served as PMO for the construction of the new Mexico City laboratory (~2,500 m²): office (~550 m²) and support areas (~500 m²), QC lab (1,200 m²), and stability chambers (250 m²) — a 12-month project from engineering to final delivery, with construction completed in just 6 months during the pandemic, and COFEPRIS and Health Canada audits passed successfully.

•      Managed the construction project of the new quality control laboratory and the refurbishment of the stability area. •      Developed the URS for construction, equipment, and utilities procurement for the new laboratory. •      Led computerized systems validation, transport chain validation, and qualification of laboratory equipment and embedded systems. •      Developed and implemented the quality system and trained teams in risk-based quality management. •      Authored CAPAs and risk-mitigation action plans and participated in audits (headquarters and regulatory agencies). •      Managed third parties and service suppliers and provided technical support to quality areas.

•      Managed refurbishment and startup projects for quality control laboratories, including commissioning and startup. •      Qualified laboratory equipment and validated computerized systems. •      Implemented risk-based assessment and provided technical advisory to operational areas. •      Managed and controlled the maintenance of clean and black utilities and developed SOPs.

•      Led sales and marketing of consulting, engineering, and construction services for the pharmaceutical, chemical, cosmetics, veterinary, sanitizing, and food industries. •      Managed the integrated offering of the Telstar Life Science Value Service group (SVS, Pharmaster, TPRO, and Duelectron).

•      Grew sales by 80% and revenue by 120%, with a strong focus on client retention. •      Expanded the team from 7 to 14 direct employees and managed three business segments, totaling 44 people (10 direct and 34 indirect). •      Implemented the company's Human Resources function and Quality System. •      Integrated teams during a merger process.

•      Developed and implemented quality systems for pharmaceutical, veterinary, and cosmetics industries. •      Led readiness audits for WHO, EMEA, and FDA certification and the commissioning of new pharmaceutical plants. •      Supported project engineering in conceptual designs and Design Qualification (DQ). •      Qualified production and laboratory equipment, including thermal qualification of autoclaves, ovens, and climatic chambers, and utilities (water, HVAC, compressed air, nitrogen). Acted as project manager for qualification, validation, commissioning, and startup of pharmaceutical plants.

•      Developed and implemented quality systems for pharmaceutical, veterinary, and cosmetics industries. •      Led readiness audits for WHO, EMEA, and FDA certification and commissioning of new plants. •      Qualified production and laboratory equipment (thermal qualification and utilities) and supported engineering in DQ. •      Coordinated qualification, validation, commissioning, and startup projects for pharmaceutical plants.

•      Responsible for the Microbiology Laboratory: managed and executed the analytical routine and product release. •      Specified, selected, and purchased laboratory equipment, materials, and service suppliers. •      Prepared the area for national and international inspections by the German headquarters and the regulatory agencies ANVISA, ANMAT, EMEA, and INVIMA.

Worked in the analytical routine of a pharmaceutical laboratory.

Estagiária de desenvolvimento de novos princípios ativos, desenvolvimento de produtos e controle de qualidade.