# Daniela Cardeal > International Quality Lead at Genentech with an M.S. in Global Health/Epidemiology (UCSF, UC Berkeley). I translate scientific knowledge into impactful global health and quality strategies. Location: Alameda, California, United States Profile: https://flows.cv/danielacardeal Senior Quality & Clinical Operations Leader | 15+ Years Experience Accomplished International Quality Lead with over 15 years of experience in the pharmaceutical and healthcare sectors, currently driving global Quality Assurance strategies within the Genentech/Roche network. Expert in managing the full lifecycle of clinical trials (Phase Ib–IV) and transforming quality management into a strategic business driver. Demonstrated ability to deliver financial results, having previously architected clinical operations for a R$ 60million business unit at 3M, generating R$ 2.2 million in additional income in a single year through the successful market introduction of 2 new medical devices. Currently providing technical oversight for a R$ 1.5 million research grant at FAPESP, while leading global audit programs and cross-functional teams to ensure inspection readiness and operational excellence. ## Work Experience ### Global Advancing Inclusive Research Site Alliance Strategy Lead - Rotation @ Genentech USA Jan 2025 – Present | California, United States I am responsible for designing and executing a global strategy to embed inclusive research principles — Access, Inclusion, and Representation (AIR) in priority countries in Latin America. ### Senior Quality Lead @ Genentech USA Jan 2022 – Present | United States I support the Roche/Genentech Organization through the design and delivery of Quality Assurance strategies for Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and Computer Systems (CS). ### Research Committee Member @ Hospital das Clínicas da Faculdade de Medicina FMUSP Jan 2024 – Present I provide technical assistance in protocol design, research operationalization and disease surveillance. This supports ADEE 3002, a medical research cohort that began enrolling patients in 1987 and conducts several sponsored, investigator initiated and epidemiological studies in a population of People Living with HIV (PLHIV). ### Global Studies Manager @ Genentech USA Jan 2020 – Jan 2021 | United States I was accountable for the delivery of the operational components of assigned clinical studies from Phase Ib-IV in line with the Asset and Therapeutic Area (TA)/Disease Area (DA) strategy, including timelines, budget and quality expectations, as well as timely and accurate data entry in our systems. ### Senior Compliance Process Training and Systems Advisor @ Genentech USA Jan 2016 – Jan 2020 I Provided leadership through partnerships/collaboration with site leadership, SMEs, Process Owners, Regulatory Compliance and key stakeholders, to oversee execution of program management activities for compliance improvements. ### Study Start-up Specialist @ Genentech USA Jan 2016 – Jan 2016 | United States I was accountable for the global execution of site activation for assigned trials. I assured start-up was efficient, timely and in accordance with ICH/GCP and Standard Operating Procedures (SOPs). ### Clinical Designer/ Project Manager @ Healthways Jan 2015 – Jan 2015 | São Paulo Area, Brazil I was focused on helping people with chronic diseases to manage their health with life-changing products that provide accurate data to drive better-informed decisions. I was accountable for the design and delivery of a population health management, web-based platform to improve health care outcomes and decrease costs. ### Clinical Research Specialist @ 3M Health Care Jan 2013 – Jan 2015 | Sumaré - Brazil I was responsible for the alignment of 3M Science (USA & Brazil) goals and strategies through joint planning and integrated governance frameworks to pivot the enterprise portfolio from imported to locally New Product Development (NPD) process. ### Ambulatory manager, Study Coordinator, Research Manager @ Clinicas Hospital - University of São Paulo - HCFMUSP Jan 2008 – Jan 2015 | São Paulo, Brazil I prepared research proposals, reports and publications independently and collaboratively resulting in five peer-reviewed articles. Provided consultation on study design, analysis plans and interpretation of study results. ## Education ### Master of Science - MS in Tropical Disease and International Health Institute of Tropical Medicine, University of São Paulo, Brazil ### Visiting Scholar University of California, San Francisco ### Visiting Scholar University of California, Berkeley ### Bachelor of Science (BS) in Registered Nursing São Paulo City University, São Paulo, Brazil ### Doctor's Degree in Health Services/Allied Health/Health Sciences, General University of Bath ## Contact & Social - LinkedIn: https://linkedin.com/in/danyrn --- Source: https://flows.cv/danielacardeal JSON Resume: https://flows.cv/danielacardeal/resume.json Last updated: 2026-04-13