Vanessa Morais

14 years of experience in Quality & Compliance and Quality Logistics department in both multinational and national companies, as well as in new markets affiliate setup of pharmaceutical business, commercial launch, post marketing quality activities (complaint, recall), distribution and commercial products, ensuring the compliant affiliate setup, structure, interdependencies and supply with medicinal products in accordance with regulatory expectations and applicable quality standards. 
Committed to positively influencing peers in a culture of integrity, passion, courage and innovation.
Manage multiple projects and prioritize tasks to meet deadlines.

Manager, Distribution and Regional Quality, New Markets

Beigene Brasil Ltda (Jul/2023 - Present).
• Responsible Person (Pharmacist) in charge of the warehouse facility.
• In country disposition/ release activities for Brazil market and issuance of Certificate of Compliance for product commercialization.
• Support commercialization and clinical trials in New Markets for all BeiGene and partner products and deliver high-quality products to our patients, in compliance with Good Manufacturing Practice (GMP) Good Distribution Practice (GDP) requirements.
• Perform quality oversight for local distribution activities in New Markets.
• Support activities for market action and product recall (mock recall) in New Markets.
• Review and approve product complaints, temperature excursions, deviation investigations and CAPA plan.
• Perform Due Diligence visits for local distributors and Quality oversight for local secondary distributors (wholesale dealers).
• Provide Quality support to implement robust and transparent Quality Governance review processes such as Management Review and Quality Review Board.
• Provide Quality guidance of cGMP/GDP for cross functional groups to ensure compliance with KPI targets including functional Quality as required.
• Assess and revise, as needed, SOPs for GMP/GDP Quality functions and identify opportunities to streamline systems and processes.
• Monitor performance metrics and drive continuous improvements of internal processes.
• Implement and manage Quality Assurance System and QMS.
• Maintain local quality procedures and input into global policy, SOP, and guideline development.
• Qualification and oversight of 3rd party providers – audits, quality agreements, monitoring activity, participate in KPI and business reviews.
• Participate/ respond to corporate audits and self-assessments and self-inspection for Brazil.
• Management of temperature sensitive products including lane qualifications, shipper qualification, temperature excursion assessments, transport validation.
• Quality subject matter expert for ANVISA and VISA inspection and communication.
• Perform Gap assessments to ensure alignment to ANVISA and VISA requirements.
• Manage and/or approve relevant change control relating to Brazil product (new product introductions/lifecycle changes/distribution readiness).
• GxP training content development and delivery for Brazil staff.
• Provide support to Supply Chain with activities of interface, as needed (return of goods, temperature excursion, others).
• Brazil point-of-contact/SME for global networks.
• Participate in the Annual Product Review.
• Quality input into state based, commercial tenders and/or hospital formulary.

Quality Assurance & Compliance Coordinator.

Bristol Myers Squibb (Jan/2022 - Jun/2023).
• In country disposition/ release activities for Brazil market and issuance of Certificate of Compliance for product commercialization.
• Responsible for contact CMOs in cases of issues detected during local warehouse activities in regard to imported products.
• Support CMOs investigations, as required.
• Evaluation of temperature loggers during the importation of products, temperature excursion assessments.
• Responsible to issue the temperature loggers assessment for biologic products for custody term release by ANVISA.
• Responsible for the change control impact assessment and required activities for new product introductions in Brazilian market.
• Responsible for coordinating local mock recall activities. 
• Responsible for sample retention room, inventory management.
• Management of the deviation system, approve CAPA plan and root cause analysis.
• BMS Trainer/Coach for root cause analysis (Instructor).
• Responsible for reporting Quality metrics and monthly market updates, prepares Deep Dives and trending analysis. 
• Learning management system administrator of local GMP/GDP training programs and curriculums for GxP functions.
• Management of Quality system documentation acting as a local administrator.
• Management of QMS compliance on site.
• Certified BMS Auditor for warehouse and distribution centers, GMP support services and third-party laboratories.
• Qualification of third parties (suppliers, distributors (wholesale dealers) and service providers), issuance of audit reports, approve and follow-up of CAPA plans and establish Quality Agreements.
• Prepare the site annual self-inspection plan, perform internal audits, issuance audit reports, coordinate and track corrective/preventive actions.
• Lead preparations for Health Authorities inspection.
• Lead preparations and participate of corporate/global audits.

Quality Assurance Coordinator

Celgene Brasil Ltda (Apr/2018 - Dec/2021).
• Responsible Person (Pharmacist) in charge of the warehouse facility.
• In country disposition/ release activities for Brazil market and issuance of Certificate of Compliance for product commercialization.
• QA logistics activities at the Logistic Operator facility (inbound process of finished goods, storage, sampling process, temperature excursions and environmental monitoring conditions).
• Implementation of QMS at the warehouse facility and QC lab.
• Implementation of Business Continuity Plan for warehouse and laboratory facility. 
• Responsible for coordinating local mock recall activities.
• Support annual inventory activities.
• Support product quality complaints and return of goods.
• Support and maintenance of necessary operating licenses for the warehouse and QC lab.
• Management of the Deviation system, approve CAPA plans and root cause analysis.
• Management of the Change Control system.
• Qualification of third parties (suppliers, distributors (wholesale dealers) and service providers), issuance of audit reports, approve and follow-up of CAPA plans and establish Quality Agreements.
• Prepare the site annual self-inspection plan, perform internal audits, issuance of audit reports, coordinate and track corrective/preventive actions.
• Management of Validation Master Plan of QC lab.
• Management of local projects with regards to Computerized System Validation & Data Integrity.

Corporate PMO Sr Analyst (Jan/2018 - Apr/2018).

Libbs Farmacêutica Ltda (Jun/2015 - Apr/2018).
• Kick-off meeting of new development projects to define objectives, resources, restrictions, deadlines, and project schedule.
• Conduct product development meetings through the interface with stakeholders.
• Management of project milestones. Monthly reports to the Director and Area Manager.

Position: Validation Analyst (Jun/2015 - Dec/2017).
• Support GMP & self-inspection audits.
• User Requirements revision regarding business and ANVISA, FDA 21 CFR Part 11 requirements.
• Execution of computerized system validation of automation equipment at the manufacturing site.
• Validation Master Plan maintenance and software inventory.
• FAT and SAT qualifications.
• Cloud systems validation and go-live of drug traceability systems.
• Media fill tests execution of biological & oncological products.
• Support yellow fever vaccine project regarding transport validation activities.

Validation Analyst (Apr/2014 - Jun/2015).
Laboratórios Baldacci LTDA (Apr/2013 - Jun/2015). 
• ERP system key-user.
• Administrator role of learning management system.
• Administrator role of the document management system.
• Validation Master Plan maintenance and software inventory.
• Go-live of Quality systems (i.e., Deviation, CAPA, and Change Control systems).
• Support Supplier Qualification process, including audits and final reports. 
• Support Self-inspection plan and exercises.

Quality Assurance Analyst (Apr/2013 - Mar/2014).
• Administrator role of learning management system.
• Perform Periodic & Annual Product review and issue reports. Perform process analysis through Minitab statistical software.
• Support during cleaning validation activities, as well as equipment visual inspection, swab and rinse-testing after cleaning process of manufacturing equipment, campaign validation, etc.
• Revise SOPs and WIs, as well as to conduct training. Management of training matrix and training schedules. Training adherence verification and compliance.
• Reverse osmosis water system startup and performance of qualification tests with the system vendor.

Validation Analyst.
 Farmoquímica LTDA (Jul/2011 - Apr/2013). 
 

Validation Intern.
 (Hypermarcas Group) (Mar/2010 - Jun/2011). 

• Postgraduate lato sensu /Executive MBA in Business Administration: Industrial Management - Fundação Getúlio Vargas - (2016 - 2018).
• Innovating at the Intersection of People and Information Technologies - mediaX Executive Leadership Workshop International Extension - FGV MBA - Stanford University - Palo Alto - CA - (2017 - 2017).
• College degree in Pharmacy with specialization in Biochemistry - Universidade Paulista - (2008 - 2011).