Quality Assurance Director

Our client is a growing clinical research organization dedicated to delivering high-quality Phase I–IV clinical trial execution, helping sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. With deep expertise in specialist therapeutic areas, the organization has completed thousands of trials and continues to expand into high-need therapeutic areas across the U.S. and globally.

Job Description:

This 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. This is a leadership role, and the ideal candidate will have experience mentoring and leading others.

Responsibilities:

Quality Management of the Clinic:

• Lead and conduct audits of study documents, Case Report Forms, Clinical Study Reports, and other supporting documentation to ensure compliance
• Collaborate with the 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 the 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 report results of audits to the VP, QA)
• Assist with supporting Regulatory (FDA, EMA, etc.) Inspections and preparation activities
• Oversee training conducted in accordance with SOPs and report metrics to Operational Leadership for required management and next steps
• Oversee all Document Control activities for the site, and for other sites as requested by 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
• Fully manage all aspects of the electronic Quality Management System as it applies to the site (and to the organization 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

Corporate QA Team (Quality Mobile Unit):

• Member of a professional team focused on clinical quality assurance/quality control and compliance-related activities in support of clinical programs and activities
• Assist in maintaining 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
• Assist in audit activities in the areas of Vendor Audit Management, facilitation of internal & external clinical quality audits, and agency inspections
• Participate in the oversight of Corrective and Preventive Actions (CAPA) implementation and assist in conducting Quality reviews
• Perform other tasks/duties as assigned by the VP QA
• Potential travel to other portfolio sites to assist with QA initiatives, internal audits, regulatory inspection support, etc., as applicable and assigned

Skills and Qualifications:

Education and Experience:

• 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)

Requirements:

• 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)