Position Summary

The Associate Director of Quality will be responsible for leading, managing, and continuously improving the quality assurance framework across a multi-site network of clinical research sites. This critical role ensures all clinical research activities, documentation, and site operations consistently adhere to regulatory requirements (e.g., FDA, ICH-GCP, HIPAA), sponsor protocols, and internal Standard Operating Procedures (SOPs). The Associate Director will drive a culture of Quality Assurance (QA) and Good Clinical Practice (GCP) compliance, overseeing auditing, training, document governance, corrective and preventive actions (CAPA), and regulatory inspection readiness across all sites.

Key Responsibilities

• Work closely with Operational Leaders, Site Managers, and Clinical Research Coordinators to integrate quality practices into daily operations.
• Establish quality policies and a robust compliance infrastructure to standardize processes and mitigate risk across all network sites.
• Develop and deliver specialized GCP, regulatory compliance, and quality assurance training programs for site staff across the network, ensuring all personnel maintain the required level of competence. Ensure the maintenance of accurate and auditable training records for all clinical personnel across the network.
• Manage the SOP lifecycle, including drafting, reviewing, approving, distributing, and ensuring consistent implementation of standardized operating procedures across all network sites.
• Design and execute a comprehensive, risk-based internal auditing program for all clinical sites to proactively identify areas of non-compliance and systemic issues.
• Develop and track metrics to monitor GCP compliance trends and the effectiveness of network-wide operational controls. Analyze network-wide compliance data and quality metrics to identify systemic weaknesses and drive continuous process improvement initiatives across all sites.
• Host and attend external audits and regulatory inspections (e.g., FDA/EMA inspections) by sponsors or health authorities and manage preparation and follow-up for the on-site inspection process.
• Serve as the primary quality and regulatory expert resource for all clinical research sites in the network, interpreting complex regulations.
• Participate in strategic planning for process improvement, focusing on standardization and high-quality data integrity throughout the trial lifecycle.

Required Qualifications

• Education: Bachelor’s degree in life science, healthcare, or related field.
• Experience: Minimum of 5 years of experience in Quality Assurance or Quality Control within the clinical research or pharmaceutical industry.
• Technical Skills/Systems Experience: Extensive, expert-level knowledge of ICH-GCP guidelines, FDA regulations (21 CFR Parts 11, 50, 54, 56, 312, 812), and HIPAA.
• Other Requirements: Ability to travel to network sites as required (Estimated 40% travel).

Preferred Qualifications

• Minimum of 3 years of management or leadership experience in a multi-site or network environment.
• Experience managing quality during rapid organizational growth or system integration across multiple locations.
• Demonstrated experience presenting complex compliance issues and strategic solutions to executive management.

Core Competencies / Skills

• Exceptional leadership, coaching, and team-building skills, particularly in a dispersed, multi-site setting.
• Strong analytical skills with the ability to perform root cause analysis and implement effective solutions.
• Excellent written and verbal communication skills for effective interaction with site staff, senior management, sponsors, and regulatory agencies.
• Proven ability to work independently, manage multiple priorities, and meet deadlines.