Quality Assurance Director

About the role

This role is based at our largest site, Clinical Pharmacology of Miami (CPMI). The Director’s primary role is for ensuring that day-to-day clinical trial operations at the CPMI 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.

Responsibilities

• Lead and conduct audits of study documents, Case Report Forms, Clinical Study Reports, and other supporting documentation to ensure compliance
• Collaborate with Site Director and study PIs to resolve and document issues promptly and effectively
• Conduct GCP compliance audits of vendors in accordance with Standard Operating Procedures
• Report significant Quality issues to Vice President, Quality Assurance
• Oversee the implementation of corrective actions with support of the Site Director and VP of Quality
• Facilitate Sponsor Audits and assist with other Sponsor site visits as applicable (and to report results of audits to Vice President, QA)
• Assist with supporting Regulatory (FDA, EMA, etc) Inspections and preparation activities
• Oversee training is conducted in accordance with SOPs and reports metrics to Operational Leadership for required management and next steps
• Responsible for facilitating Document Control activities for the site, and for other sites as requested from the VP of QA
• Ensure the appropriateness and effectiveness of site CAPA investigations and oversee timely and accurate reporting of results to applicable stakeholders, including Sponsors, CROs, and IRBs
• Responsible to fully manage all aspects of the electronic Quality Management System as it applies to CPMI (and to ERG as a whole under the direction of the VP of Quality)
• Play a key role in site leadership and client engagement, ensuring clear communication, professionalism, and alignment with Operational Leadership and the Quality Assurance Department
• Supervise direct reports supporting Quality Assurance and Quality Control efforts on clinical trials

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 Spanish highly preferred
• 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)
• Strong understanding of FDA regulatory requirements, Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) guidelines
• Knowledge of medical terminology
• Excellent organizational and prioritization skills with the ability to adapt in a dynamic, changing environment
• Strong analytical and problem-solving abilities
• Ability to provide accurate guidance and support on regulatory requirements
• Excellent documentation practices and attention to detail
• Ability to travel as requested by the Vice President of QA
• Exceptional communication skills (interpersonal, written, and verbal)
• Proficiency in computer applications, including Microsoft Word and Excel, and familiarity with clinical research systems (e.g., Clinical Trial Management Systems)