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.

Why join? A supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Competitive benefits include medical and dental coverage, a matching 401(k), and paid time off.

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.

Oversight and communication with the Operational Team may include (but is not limited to):

• Conducting internal audits
• Monitoring training completion and associated metrics
• Providing support and consultation for Quality events and CAPAs
• Overseeing and assisting with internal and external audits
• Managing and supervising Quality Control plans and QC staff
• Maintaining all Quality-related activities within the clinic

Additionally, 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.

As needed, or in the absence of the Vice President of Quality Assurance, this role may assume leadership of the Corporate QA Team, oversee the planning, execution, and analysis of Quality Assurance initiatives, as well as managing external audits for the organization. This position reports directly to the Vice President of QA.

In fulfilling these responsibilities, the site-based Quality Assurance and Compliance Director operates in alignment with FDA regulations, Good Clinical Practice (GCP) guidelines, and the company's standard operating procedures and policies.

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)