Open to opportunities

Luciana Marchese

@lucianamarchese

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Experienced GLP auditor with a strong focus on quality assurance.

Brazil

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What I'm looking for

I seek opportunities to leverage my extensive QA expertise in the medical and pharmaceutical industries, focusing on regulatory roles that promote quality and compliance.

I am a dedicated Quality Assurance Specialist with over 24 years of extensive experience in internal and external audits, primarily within a multinational environment. My career has been marked by a commitment to identifying gaps and opportunities for improvement, ensuring compliance, and enhancing processes. I take pride in my strong interpersonal skills and my ability to communicate effectively, which has allowed me to build productive relationships with stakeholders across various levels.

Throughout my tenure at Corteva Agriscience and Dow AgroSciences, I have served as a Subject Matter Expert on GLP, leading the harmonization of evaluation processes and conducting audits across multiple countries. My proactive approach has enabled me to support the implementation of GLP in various regions, ensuring that organizations meet both corporate policies and regulatory requirements. I am passionate about mentoring others and have developed training programs to enhance the skills of my colleagues in quality assurance practices.

Experience

Work history, roles, and key accomplishments

Global CRO GLP Specialist

Corteva Agriscience

Jan 2018 - Dec 2024 (6 years 11 months)

Served as a Subject Matter Expert on GLP, providing critical guidance to key stakeholders and leading the harmonization of Contract Research Organizations' GLP evaluation processes globally. Conducted extensive on-site and remote audits across multiple countries, ensuring compliance with corporate policies and regulatory requirements. Supported CROs in South Africa with GLP implementation and assi

GLP Quality Assurance Audit Management Regulatory Affairs SOP Development Stakeholder Management Process Harmonization CRO Data Analysis Project Coordination

Quality Assurance Unit

Dow AgroSciences

Jan 2006 - Dec 2012 (6 years 11 months)

Participated in regulatory inspections as a lead Quality Assurance professional, managing pre, during, and post-audit activities. Conducted comprehensive GLP study-based and facility audits, including those of Contract Research Organizations, to ensure continuous compliance with regulatory requirements. Developed, reviewed, and revised Standard Operating Procedures and quality manuals, and identif

Quality Assurance SOP Development Training Development Compliance Management Audit Reporting

GLP Focal Point for Latin America

Dow AgroSciences

Jan 2012 - Present (13 years 6 months)

Coordinated GLP activities and projects across Latin America, including Brazil and Argentina, to facilitate global product sales. Supported Contract Research Organizations in Argentina with GLP implementation, ensuring adherence to company and regulatory standards. Conducted GLP study-based and facility audits, while also reviewing and writing SOPs and quality manuals to maintain compliance and al

GLP Quality Assurance Audit Management Regulatory Compliance SOP Development Project Coordination Latin American Market

English Teacher

American Way Language School

Jan 2003 - Dec 2006 (3 years 11 months)

Taught basic English to a diverse range of students, including children, teenagers, and adults. Developed and delivered engaging lesson plans tailored to different age groups and learning styles. Fostered a positive and effective learning environment, contributing to student language proficiency.

Curriculum Development Lesson planning Classroom Management Communication Skills Interpersonal Skills Educational Technology Cultural Sensitivity Public Speaking

Quality Consulting

Various Companies

Jan 2001 - Present (24 years 6 months)

Provided quality consulting services across Brazil, specializing in the implementation of Quality Management Systems. Successfully established and optimized quality frameworks for two medical clinics, one veterinary clinic, and a bus company. Ensured adherence to industry standards and improved operational efficiency for diverse clients.

Quality Management Systems Consulting Client Relations Business Process Improvement Documentation Training Strategic Planning

Quality Assurance Unit

Ecotoxicology Lab (University of Sao Paulo)

Jan 2000 - Dec 2006 (6 years 11 months)

Successfully implemented the Good Laboratory Practices (GLP) system within the Ecotoxicology Laboratory. This initiative enabled the laboratory to offer services to industry clients and significantly supported research funding initiatives. Ensured the laboratory's operations met stringent quality and regulatory standards.

GLP Quality Assurance Laboratory management Regulatory Compliance Service Development Process Improvement

Education

Degrees, certifications, and relevant coursework

Center for Nuclear Energy in Agriculture – CENA (University of São Paulo)

Master's in Sciences, Chemistry in Agriculture and Environment

Completed a Master's in Sciences with a focus on Chemistry in Agriculture and Environment. This program provided advanced knowledge in environmental chemistry and its applications in agricultural contexts.

Institute of Technology Improvement (IAT) and Piracicaba University of Engineering (EEP)

MBA, Quality Management

Obtained an MBA in Quality Management, focusing on principles and practices of quality assurance systems. This included studies on ISO standards and their implementation in various industries.

University of Agriculture “Luiz de Queiroz”(ESALQ/USP)

Bachelor's in Agricultural Engineering, Agricultural Engineering

Graduated with a Bachelor's in Agricultural Engineering, gaining comprehensive knowledge in agricultural sciences and engineering principles. The curriculum covered various aspects of modern agriculture.