Raquel Marques Email and Phone Number

Independently lead all Quality related activities at the country/cluster level, ensuring compliance with applicable regulatory standards, quality system requirements and company policies. Strategic and Leadership role oversighting all countries in LATAM and Puerto Rico ensuring all facets of operational business adhered to cGMP and GxP requirements, regulations FDA 21 CFR 210, 211, 201, 330 and 820, ISO 13485, legal and regulatory as well as Alcon Quality Manual. Executing business decisions related to quality in distribution for the Region. Ensure the KPIs. Confirming quality management system by administering quality plans, quality agreements, internal and external audit schedule, training program, escalations, market actions, supplier management, warehouse operations (redress, re-packaging, temperature mapping, returns), transportation operations (cold chain products) and complaints. Maintaining high performance by recruiting and training employees.

Actively delivering quality management for LACAR affiliates in Northern Region ensuring all facets of operational business adhered to cGMP and GxP requirements, regulations FDA 21 CFR 210, 211, 201, 330 and 820, ISO 13485, legal and regulatory as well as Alcon Quality Manual. Executing business decisions related to quality in distribution for all Northern Affiliates. Confirming quality management system and quality in distributions operations for all Northern Affiliates by administering quality plans, quality agreements, internal and external audit schedule, and training program. Maintaining high performance by recruiting and training employees. ▪ Participation of Kaizen events and part of the community for QMS transformation project focusing on Non-conformance, CAPAS and Supplier Management.

QA Head of North America affiliate GxP functions (warehousing, distribution, transportation, redressing, labelling approval, customer service) to ensure compliance with all applicable quality regulatory, GMP, GDP, ISO, and Novartis Quality Manual requirements.

Distribution QA Head of LACAR affiliate GxP functions (warehousing, distribution, transportation, redressing, labelling approval, customer service) to ensure compliance with all applicable quality regulatory, GMP, GDP, ISO, and Novartis Quality Manual requirements.• Provided Quality oversight for all LACAN Affiliates in South America, Central America and North America ensuring that all aspects of the operational business complied with cGMP, GxP, legal and regulatory requirements as well as the Novartis Quality Manual.• Made decisions for the business related to quality in distribution for all Affiliates in LACAN such as new warehouses, warehouse layouts, temperature mapping, product under quarantine, redress, transportation, products to be destroyed, investigations and disposition.• Ensured Quality Management System and Quality in Distributions Operations for all Affiliates in LACAN by managing Quality Plans, Quality Agreements, Internal and External Audit Schedule, Training Program.• Utilized scorecards to identify quality issues and trend CAPA implementation. • Responsible for maintaining staff by recruiting, selecting, training and coaching the employees and developing personal growth opportunities.• Implemented a consistent quality culture and quality organization across the Region by driving together with the Regional Commercial Leadership Team and General Managers.• Lead Regional Country Quality Review at Regional Commercial Leadership Team meetings attending monthly meetings with President of LACAR.• Visited the Affiliates sites, Alcon Warehouses and 3PLs and promoted face to face meeting with the team.• Lead and influence Quality Culture at the country level and at Regional Commercial Leadership Team.• Provided strong and consistent communication, technical guidance and support by performing 1:1 meetings with GMs and QA heads as well as monthly meetings.

QA support and oversight of the LACAR affiliate GxP functions (warehousing, distribution, transportation, redressing, labelling approval, customer service) to ensure compliance with all applicable quality regulatory, GMP, GDP, ISO, and Novartis Quality Manual requirements. Responsible for ensuring that the Americas Distribution/Global Transportation organization, including its LACAR/Canada affiliates meets Alcon’s corporate, regulatory and industry standards and helps achieve superior quality and reliability levels in this area. Responsible for reviewing Distribution/Transportation Compliance documentation to ensure compliance with established quality standards and regulatory requirements in US and LACAR/Canada.  Responsible for ensuring Quality System in LACAR by supporting implementation of SOP and MSP ensuring compliance with Novartis QMs and QDs. Responsible for maintaining QA Operations in Madison Warehouse by providing training, reviewing and resolving issues of non-conforming data and initiate corrective actions within established guidelines to prevent recurrence. Responsible for maintaining the compliance of good Distribution Practices and Procedures in Madison Warehouse and LACAR/Canada. Responsible for investigating quality issues and reviews the results of Distribution Investigation in US and LACAR/Canada. Provide written reports of the findings.  Responsible for maintaining Distribution/Transportation non-conformance CAPA actions program in US and LACAR/Canada.  Responsible for ensuring Warehouse activities (redress, receipt, storage and shipment) in Madison and LACAR/Canada under QA requirements for Pharma, Surgical and Medical Devices. SME for E-Learning “Investigation Certification Program

• Responsible for managing and supervising QA operations 1st shift team;• Responsible for maintaining the product release schedule (CLC and Surgical) and improving the on time release through QA cycle time reduction of reviews.• Responsible for evaluating Reworks, Non Conformances, and CAPA actions, ensuring follow up and reporting of past due items for CLC and Surgical.• Responsible for maintaining QA Operations data for Management Review.• Provide QA Operations support for product launches.• Responsible for maintaining training plans/qualifications for QA Technicians.

• Coordinate product release ensuring a reduction in cycle time and on-time release metrics;• Support on-line inspection activities;• Write and review SOPs and ensure periodic reviews completed in timely manner;• Responsible for reviewing and closing non-conformances and CAPA;• Responsible for the QA Operations monthly report presented to the senior management.

• Write and implement protocols and technical reports for validation and requalification projects;• Perform validation, performance qualification, and requalification studies;• Schedule equipment with production personnel in order to perform validation projects;• Support other groups with specific studies.

• Responsible for coordinating and supervising around 60 operators (solids, semi-solids, and liquids production lines).• Coordination included:o Building compounding, filling and packaging teams according to the production plans.o Comply with production plan regarding schedule and date of delivery of finished good.o Following and meeting the production plans avoiding wasting, scraps, and rework.o Ensure good manufacturing practices (GMP) were followed.o Ensure standard operating procedures (SOP) were followed.o Cross training employees making the operators proficient in more than one area. • Responsible for updating and reviewing the production budget, cost planning and control.• Review equipment preventative maintenance (including calibration).• Member of the new product launch and new packaging line group: responsible for evaluating the impact and adjusting the production plans.• Member of Continuous Improvement Program group.• Special projectso SAP (ERP) implementation – includes employee trainingo Production Optimizationo Validating new packaging line (QA Validation – change/write SOPs)

• Job rotation as Packaging Supervisor coordinating 30 operators for 6 months.• Experience with sterile compounding and cleanroom. • Sterile area validation (media fill, filling machines, packaging machines, environmental monitoring, filter integrity testing, sterility testing, water testing and Gram’s Method).• Responsible for writing and reviewing Standard Operating Procedures (SOP) and MBRs• Experience working on a cleanroom (aseptic technique, horizontal laminar airflow hood, GMP) • Responsible for reviewing equipment preventative maintenance (including calibration).• Responsible for putting together and compiling all production batch records.• Responsible for training all plant employees in GMP (including cleanroom procedures).• Responsible for all finish goods delivery to the distribution center.• Interface with QA, Supply Chain, Maintenance, and Finance.• Responsible for updating and reviewing the plant budget.