Quality Assurance Manager - 242632

Seeking a Quality Insurance Manager for a well known Clinical Research Site in Dallas, TexasSummary:We are looking to add a full time Quality Assurance Manager to our growing team. This role can be based out of Dallas, TX or Montclair, CA and will require up to 25% travel. The ideal candidate must have a minimum of 3-5 years of site based Clinical Research experience in phase I-III clinical trials.The Quality Assurance Manager will be responsible for ensuring research site quality across the research site network. This will include performing on-site and remote audits, writing quality reports and Corrective and Preventative Actions (CAPAs), tracking and trending data, and site risk mitigation.Responsibilities Completes clinical investigator site audits to assess adherence to the Study Protocol and associated documents, GCP, standard operating procedures (SOPs) and applicable regulations.Prepares internal trend analysis of audit observations; addresses audit risks through Corrective and Preventative Actions and identifies and communicates to the VP of Quality Assurance any compliance risks.Works with research sites to ensure that the Research Site Visits, and Vendor Audits are scheduled and approved by the VP of Quality Assurance.This position is accountable, under the leadership of the VP of Quality Assurance, to develop and lead inspection readiness activities for Clinical Research sites.Develops, implements, and monitors processes to ensure exceptional quality at clinical research sites.Develops and implements relevant QA SOPs, as needed.Occasional travel to Company sites and/or Company meetings. Requirements:Bachelor's degree, a health science major is preferred.3+ years of pharmaceutical clinical research experience.3+ years of auditing experience.Duties and Responsibilities: The Quality Assurance Manager:Completes clinical investigator site audits to assess adherence to the Study Protocol and associated documents, GCP, standard operating procedures (SOPs) and applicable regulations.Prepares internal trend analysis of audit observations; addresses audit risks through Corrective and Preventative Actions and identifies and communicates to the VP of Quality Assurance any compliance risks.Works with research sites to ensure that the Research Site Visits, and Vendor Audits are scheduled and approved by the VP of Quality Assurance.Maintains compliance with federal, state, and local laws as well as regulations governing clinical research to ensure compliance.This position is accountable, under the leadership of the VP of Quality Assurance, to develop and lead inspection readiness activities for Clinical Research sites.Develops, implements, and monitors processes to ensure exceptional quality at clinical research sites.Represents Quality Assurance (QA) for clinical research compliance advice and guidance as needed.Develops and implements relevant QA SOPs, as needed.Effectively communicates quality issues to the management team in a timely manner.Performs other duties as assigned.Occasional travel to Company sites and/or Company meetings.

Created: 2025-06-19