Barbara Sousa Email & Phone Number

São Paulo

• Responsible for design and implement the CBRE Quality System to support the operations and processes with GXP impact, at the J&J, across the (LatAm) Latin America Region, covering Consumer, Pharma and Medical Business Units needs.• Oversight LatAm operations, suppliers and subcontracting to assure the required compliance level.• Elaborate and apply the Training Program to support the operations for regulated processes.• Establish and manage core processes KPIs.• Responsible for continuous improvement, external and internal audits.• PMO for Savings Projects.

São Paulo

• Responsible for establishing the MQO Strategic Plan, based on the risk assessment and developing the PCO Dashboard to monitor the core processes.• Responsible for managing global projects, focused on the business needs and regulatory requirements. And member of the cross-BU project team, as Quality Culture, contributing to develop the Quality Goals and Quality Reward, for designing new initiatives to promote the Quality Mindset.• Supporting to the internal audits.• Responsible for coordinating the SOP Review Process within the MQO organization.• Supporting to the • Responsible for analytical methodology validation, standard substances preparation and management, raw-material, bulk and finished product analysis, laboratory equipment qualification (such as HPLC, CG, dissolutions), and control of reagent stock.• Supply Qualification and Development Project implementation, reducing the raw material analysis costs in 60%, the lead time of finished product analysis in 20% and the lead time of raw material analysis in 30%, by optimizing the process workflow and supply chain.• Participated in the structuring of the Quality System and ISO 9002 implementation, as the first certified pharmaceutical company in Latin America.• Responsible for designing Audit Module and Report at Quest System.• Responsible for the administrative routine and technical tasks, as regional and global meetings, and knowledge transfer session.

• Responsible for Quality System implementation, focused on GMP, GCP, GPVP, GDP and GAMP requirements, External and Internal Audits, including PSP, MR, CRO and Investigational Sites Audits and Regulatory Inspections Management. • Experience in Risk Management and Crisis Management Processes.• In charge of Strategic Planning execution and controlling, working as Project Management Officer. • Team member of Global project for developing and implementing global solutions for managing Documentation and Training, and for implementing EQMS system, including the automation of the following processes: CAPA, deviation investigation, change control, supply qualifications, technical complaints and audits. And local process owner for Training, Documentation Management and Process Improvement, optimizing the policy database from 450 to 230 documents, and introducing the virtual training concept.

• Pharmaceutical Responsible for all Novartis products launched and distributed in Brazil, including investigational products and biotechnological products, since the incoming materials analysis, semi-finished and finished products analysis to the release, considering sampling, quality control, instrumental, microbiological and environmental analysis.• In charge of Quality Systems implementation related to Quality, Clinical Trial and Pharmacovigilance Processes, eliminating significant regulatory gaps. And for International, External and Internal Audits management, following and receiving Regulatory Inspections related to GMP and Post-registration Certification, facilitating the interaction between local auditees and Brazilian authorities.• Quality Culture implementation and improvement, including risk management concept, deviation investigation and CAPA definition, applicable to the shop floor, warehouse, engineering and laboratories of QC, Stability Studies and Microbiology. And adjusting site to the FDA regulation, achieving 5 regulatory inspections, 28 audits, revision of 700 procedures and 60 trainings in 2,5 years. Including Technical Training and Documentation Management, project implementation achieving 85 implemented policies through the organization in 1,5 year.• Experience in Transport Monitoring Project implementation and development of the new standardization for transportation package, reducing in R$ 1000.000 the expected costs. And saving R$ 1000.000 / year qualifying Raw Material Suppliers.• QA expert for engineering projects QA e-Compliance for GXP automated systems.

• Responsible for the development of policies, guidelines and procedures to Latin America affiliates focusing on Manufacturing Process and Computer Systems Validation.• Latin America and local Project Manager for Trackwise System Implementation.

• Responsible for coordinating 7 validation projects at the same time, with a team of 13 professionals reporting to Quality Assurance Manager, including SAP-R3 system validation project (pioneer implementation), manufacturing processes, transferring analytical methods, qualifying installations, operations, equipment, utilities and other information systems. Including the establishment of key indicators for validation, converting qualitative data into quantitative one, reducing costs in 30% (approximately R$ 500.000). 25% Reduction of semi-solids production costs by optimizing manufacturing process• Local manager of International Temperature Monitoring Project.• Creator of educational campaign and training of validation culture awareness, reducing deviation reports on 2003 in 67%.• Participation on the achievement of GMP Certification by headquarter and ANVISA. • In charge of budget control, personnel administration and coordinating quality assurance activities including documentation management, audit systems, product approval and rejection, and approximately 60% reduction of returned documentation by deviation.

• Responsible for Training and Documentation Management System development project, technical training process implementation, internal and external audits. • Validation of the sterilization process, technical support to health professionals and costumers, complaint investigations and for adapting the policies and guidelines from the headquarter to Brazil. • In charge of batch record review and product release.

• Responsible for analytical methodology validation, standard substances preparation and management, raw-material, bulk and finished product analysis, laboratory equipment qualification (such as HPLC, CG, dissolutions), and control of reagent stock.• Supply Qualification and Development Project implementation, reducing the raw material analysis costs in 60%, the lead time of finished product analysis in 20% and the lead time of raw material analysis in 30%, by optimizing the process workflow and supply chain.• Participated in the structuring of the Quality System and ISO 9002 implementation, as the first certified pharmaceutical company in Latin America.