Melanie Pacheco-Manrique
Director, Quality, Trust, and Compliance at endpoint Clinical
- Role
- Director, Quality, Trust, and Compliance at Endpoint Clinical
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Melanie Pacheco-Manrique
Senior quality assurance professional with over 15 years of experience in the pre-clinical and clinical service provider industries and a proven track record in managing corporate quality management systems and compliance processes and methodologies, including implementation of new tools and procedures to enable the company’s continued compliance with new regulatory requirements and ensuring that client requirements and expectations are met by performing an analysis of new regulatory requirements and guidelines and working with stakeholders to identify best approach for compliance. A trusted Quality subject matter expert who continuously collaborates with other teams to ensure that regulatory requirements and guidelines are assessed for impact and that procedures, systems and products are appropriately developed and implemented. Works with product development team to review system requirements and ensure quality-by-design approach is followed early in the product life cycle. Works with Operations and IT stakeholders to identify root causes, institutionalize effective solutions, focus on solutions versus just highlighting problems, and mentor junior staff. Utilizes straightforward and respectful communication skills effectively to drive successful resolutions. Experience includes: quality systems management, oversight, and monitoring, auditing of software and services, computerized systems validation (CSV), hosting of sponsor and client audits and escalations, supporting clients during regulatory inspections, 21 CFR Part 11 Electronic Records; Electronic Signatures, and corrective action and preventive action (CAPA) management.
Experience
Director, Quality, Trust, and Compliance
Jul 2024 — Present · San Francisco, CA, US
Education
San Francisco State University
Bachelor of Science (BS)
2005 — 2006
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