Patricia Maldonado

About Patricia Maldonado

Quality* Certified quality assurance auditor with comprehensive experience conducting audits of internal processes, protocols, reports, raw data, in-progress/in-life studies, contract research organizations, vendors/suppliers, and equipment/software/method validations.* Practiced in developing and delivering highly engaging internal and external technical and compliance training, presentations, and webinars.* Extensive involvement in preparing and assessing deviation root cause investigations, CAPA plans, and change controls.* Certified Six Sigma Green Belt with in-depth familiarity leading continuous improvement projects.* Proficient in authoring SOPs, reports, quality plans, and quality agreements.* Adept in generating and communicating metrics and KPIs, analyzing trends, and evaluating risks.* Skilled in interpreting standards and regulations and carrying out inspection readiness activities. Regulatory* Extensive knowledge of FDA (21 CFR 58) and EPA (40 CFR 160) Good Laboratory Practices, OECD Principles on Good Laboratory Practices, Bioanalytical Method Validation and Study Sample Analysis Guidance (ICH M10), Electronic Records and Signatures (21 CFR 11), and veterinary Good Clinical Practices (VICH GL9). Technical* Experienced in creating databases, templates, tools, training modules, technical study plans, and communication plans.* Skilled in the use of different software systems: Microsoft Office, SharePoint, Trackwise, Veeva (Quality, Clinical, and Regulatory), Qualtrax, LIMS, EDCS (Prelude and Medrio), e-Notebooks, Regulus, MAXIMO, JMP, Minitab. Soft skills* Strong project management skills employed in leading cross-functional, global teams to deliver agreed-upon results within established timelines.* Proven strength partnering with customers and stakeholders to achieve win-win outcomes and facilitate conflict resolutions.* Passion for mentoring and sharing knowledge with others.* Fully bilingual (English/ Spanish).

Experience

1. Senior Manager, Quality Assurance

   Clinaxel

   Sep 2025 — Present · Indianapolis, IN, US

   Conduct and oversee system, process, and study-specific audits to ensure adherence to vGCP, GLP, and company standards.* Manage regulatory inspections, sponsor audits, and sub-contractor evaluations.* Develop and monitor CAPAs and ensure proper communication of outcomes.* Serve as primary liaison for quality and compliance matters related to animal health field studies.* Oversee and perform controlled document reviews, review of deviations and change control plans related to field operations.* Provide reports on QMS performance, regulatory updates, and KQIs.* Support coordination, creation, and delivery of vGCP training

Education

• The Johns Hopkins University

  M.S., Biotechnology

  2008 — 2011

• Pontifical Catholic University of Puerto Rico

  B.S., Chemistry

  1995 — 1999

Skills

• R&D
• Elisa
• Good Laboratory Practice (Glp)
• Microbiology
• Lifesciences
• Biotechnology
• Research and Development (R&D)
• Validation
• Protein Chemistry
• Cell Culture
• Quality Auditing
• Assay Development
• Quality Assurance
• Analytical Chemistry
• Change Control
• Technology Transfer
• Laboratory
• Manufacturing
• Biochemistry
• Quality Control
• Gmp
• Quality System
• Molecular Biology
• Life Sciences
• Sop
• Fda
• Capa
• Laboratory Skills
• Immunoassays
• Glp