Richard Sainz
Quality Assurance Systems Manager @Aptar
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WORK HISTORY
Quality Assurance Systems Manager @Aptar
Congers, NY, US
Responsible for the development, implementation, and continuous improvement of quality management systems (QMS) across pharmaceutical manufacturing sites. Ensuring that all processes meet rigorous international standards and global regulatory requirements, such as FDA 21 CFR and ISO 13485. Key Responsibilities:System Development: Designing and deploying QMS policies and standards for internal operations and the broader supply chain.Compliance & Auditing: Leading internal, customer, and third-party certification audits (e.g, ISO 15378, ISO 9001) to ensure global compliance.Process Improvement: Utilizing Lean Manufacturing and Six Sigma methodologies to reduce non-quality costs and minimize product deviations.CAPA Management: Overseeing Corrective and Preventive Actions (CAPA) and root cause analysis to resolve complex manufacturing issues.Leadership: Managing cross-functional quality teams and serving as a technical liaison between executive leadership and shop floor operations.
EDUCATION
State University of New York - Purchase College
B.S. Degree, Chemistry / Environmental Chemistry
Dutchess Community College
Associate's degree, Architectural Technology
Pace University-Pleasantville/Briarcliff Campus
Bachelor of Architecture - BArch, Architecture
Dutchess Community College
Associate's degree - continous, Chemistry
ABOUT RICHARD SAINZ
Diversified quality professional in the biopharmaceutical and medical device industries with experience in quality management systems, manufacturing processes, quality control, qualitative and quantitative analysis, product design and development, and clinical practices. With over 25 years’ experience, proficient in external/internal auditing, assessment and facilitation of non-conformances, corrective and preventive actions. Development of quality management systems in both established and start-up companies. Improving existing process efficiency and managing clinical and commercial product release.
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