Amanda de Rezende
Sr. Quality Leader | Sr. Program Manager | Strategic Thinker | Influential Leadership | Continuous Improvement | Quality Systems Management | Board Member
- Role
- Sr Digital Quality Program Manager at Medtronic
- Location
- Denver, CO, US
- LinkedIn followers
- 500 followers
About Amanda de Rezende
With over 18 years of experience in GxP quality systems management within pharmaceutical and medical device industries, I excel in overseeing end-to-end quality operations. As a PMP certified professional, I specialize in leading cross-functional teams, driving complex quality and IT systems transformations, ensuring compliance with regulatory standards to enhance business outcomes.My passion lies in cultivating a culture of quality and fostering stakeholder engagement through effective communication and interpersonal skills. I am a strategic problem solver, known for my ability to influence and lead with a diverse, cross-country perspective, having worked in Brazilian and North American pharmaceutical companies. Fluent in Portuguese and English, I bring a unique blend of cultural insights to drive business value. I am also community driven and am constantly striving for reduction of workplace disparities for parents, women, and LatinX, improving employees work experience.Here is a summary of how I can support highly regulated organizations with my expertise: Quality Systems Management: Training, Document Management, Audits, CAPA, Change Control, Validation, Complaint Handling, Post-Market Surveillance. GxP Compliance: Extensive knowledge of GMP, GLP, FDA, ISO standards, EU MDR, ANVISA, and ICH guidelines. Regulatory Oversight: FDA inspections, product reviews, and compliance management. Risk & Vendor Management: Supplier audits, issue resolution, and Quality Agreement development. Process Optimization: Lean Six Sigma, Kaizen, and process standardization for continuous improvement. Project & Change Management: PMP-certified with expertise in QMS integrations, IT system transformations, and stakeholder collaboration. Leadership Skills: Conflict resolution, strategic planning, and driving organizational improvement initiatives.Let\'s connect and explore how my expertise can drive quality excellence in your organization!
Experience
Sr Digital Quality Program Manager
Jan 2025 — Present · CO, US
Defining, implementing, and sustaining transformation initiatives within the Diabetes Quality Improvement Program• Aligning Transformation projects with the Digital quality roadmap and providing input to the roadmap on process digitalization opportunities e.g. automation, application of AI Technologies• Partnering with the Digital Technology team to ensure alignment on roadmap, technology availability and project planning• Guiding the architecture, governance, and measurement of the program.• Partnering with key stakeholders to lead quality initiatives that develop and maintain a high performing, scalable, and compliant Quality System.• Interpreting government regulations, agency guidelines, and internal policies to assure compliance.• Establishing and implementing meaningful metrics.
Education
Universidade Estadual Paulista Júlio de Mesquita Filho
Bachelor of Pharmacy (B.Pharm.), Drugs and Medications
2000 — 2007
Universidade Estadual de Campinas
Especialização em Sistemas de Gestão da Qualidade, Quality
2007 — 2008
Terumo BCT
Spectra Optia® Apheresis System Basic Technical Training Course for Service/Repair, Medical Device
2015 — 2015
Centro Paulista de Investigações Clínicas - CEPIC
Profissionalização em Pesquisa Clínica, Pesquisa clínica
2010 — 2010
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