QADCR

Job Description

The role is based at the organization's largest clinical research site. The Director's primary responsibility is ensuring that day-to-day clinical trial operations at the site are conducted in compliance with study protocols, FDA regulations, and ICH/GCP guidelines. This role provides oversight and reporting to Operational Leadership to maintain the integrity and quality of all site activities.

• Conducting internal audits
• Making sure training completion and associated metrics are monitored
• Supporting and consulting for Quality events and CAPAs
• Managing and supervising Quality Control plans and QC staff
• Overseeing and assisting with internal and external audits
• Maintaining all Quality-related activities within the clinic

Responsibilities

This role is part of the Corporate Quality Assurance Team, a mobile unit that provides coverage across all portfolio sites. Responsibilities include supporting the overall Quality Management System for these sites to ensure quality assurance, quality control, compliance, and auditing activities related to study conduct.

• Supporting Regulatory (FDA, EMA, etc.) Inspections and preparation activities
• Assisting with Sponsor Audits and assisting with other Sponsor site visits as applicable (and reporting results of audits to the VP, QA)
• Assisting in the maintenance of the organization's Quality Management System (QMS), inclusive of the eQMS, to ensure compliance with Good Clinical Practice (GCP) and alignment with internal policies and standard operating procedures
• Assisting in audit activities in the areas of Vendor Audit Management, facilitation of internal & external clinical quality audits, and agency inspections
• Participating in the oversight of Corrective and Preventive Actions (CAPA) implementation and assisting in conducting Quality reviews

Qualifications

• Thorough understanding of Good Clinical Practices (GCP), Code of Federal Regulations (CFR), and HIPAA as they apply to clinical research
• Bachelor's degree or higher in life sciences, medicine, or a related field (or equivalent experience)
• Bilingual in Spanish and English (Essential)
• Minimum of 10 years in the pharmaceutical, clinical, or medical device industry, including conducting internal and external audits
• At least 5 years of experience participating in FDA or other regulatory agency inspections (preferred)
• Extensive experience managing CAPA programs with a focus on GCP compliance, ensuring timely completion and deliverables
• Background in project management, site leadership, or oversight of high-volume clinical trials strongly desired
• Experience with 21 CFR Part 11 and aspects of Computer System Validation (preferred but not required)