Senior Director, Project Quality

About the role

The Senior Director, Project Quality role is a senior leadership opportunity focused on strengthening project quality and regulatory compliance across a multi-site clinical research organization. Key responsibilities include building and managing a company-wide Quality Management System, leading QMS reviews, establishing quality compliance processes, guiding operational teams, and supporting sponsor audits and regulatory inspections.

Responsibilities

• Build, implement, and manage a company-wide Quality Management System, including controlled documentation and ongoing maintenance of quality requirements.
• Lead required QMS reviews and oversee the research, implementation, and management of an electronic QMS solution across all sites.
• Partner with site heads and directors to establish, maintain, and continuously improve quality compliance processes.
• Establish and lead the Project Quality team, defining staffing needs, qualifications, training requirements, responsibilities, and operating processes.
• Oversee the execution of quality management activities across sites, including quality management plans, risk management, quality improvement initiatives, and Quality Evaluations.
• Collaborate with Process Quality teams to identify and implement quality-related process improvements and SOP harmonization initiatives.
• Provide expert guidance on quality, risk, and regulatory compliance while supporting business objectives and sponsor-facing quality requirements.
• Guide operational teams through quality issues, investigations, root cause analysis, corrective and preventive actions, and follow-up activities.
• Monitor and report quality performance, trends, key issues, CAPAs, and risk indicators to site personnel and senior leadership.
• Support the use of the electronic QMS for study-level quality management and collaborate with support functions on quality aspects of site integrations and vendor management.
• Lead site preparation for sponsor audits and regulatory inspections, including supporting response letters and quality-related communications with sponsors, IRBs, and the FDA.
• Review and interpret audit, inspection, complaint, and quality reports to identify risks and ensure patient safety and data integrity.
• Lead operational quality meetings to share lessons learned, best practices, performance trends, and opportunities for improvement across sites.
• Monitor site compliance with FDA guidance, SOPs, GxP requirements, and applicable clinical research standards.
• Provide strategic recommendations and quality performance reporting to senior leadership, highlighting organizational strengths, emerging risks, and areas requiring action.

Requirements

• Master’s degree or equivalent qualification.
• At least 8 years of experience in quality and compliance management within a clinical research environment.
• Strong understanding of clinical research activities and processes within hospital, clinic, or research-site settings.
• Expert knowledge of clinical research Quality Management System requirements and quality management practices.
• Comprehensive understanding of clinical research processes and research site conduct.
• Expert-level knowledge of quality issue identification, triage, root cause analysis, CAPA, risk assessment, and impact analysis.
• Expert working knowledge of GCP guidelines, applicable regulations, regulatory documentation, and IRB submission requirements.
• Strong understanding of clinical research data compliance and best practices for organizing and managing quality at research sites.
• Demonstrated ability to lead cross-functional initiatives, influence stakeholders, and build strong relationships between quality and operations.
• Proven leadership capabilities, including mentoring, training, and developing employees at different levels.
• Excellent interpersonal, communication, organizational, and problem-solving skills, with the ability to be assertive, persistent, flexible, and collaborative.
• Proactive and self-directed approach with the ability to manage competing priorities and keep teams focused on objectives.
• Exceptional attention to detail and strong organizational skills.
• Excellent written and verbal communication skills.
• Strong proficiency with Microsoft Office 365 and other business technology tools.
• Able to work independently, exercise sound judgment, and influence decisions when appropriate.
• Willingness and ability to travel up to 30%, with occasional evening or weekend work as required.
• Comfortable working remotely and using computer-based systems throughout the workday.

Benefits

• Health, dental, and vision insurance plans.
• 401(k) with a 100% employer match on the first 4% of employee contributions.
• Tuition reimbursement.
• Employee referral program.
• Employee assistance program.
• Life insurance.
• Disability insurance.
• Generous paid time off covering vacation, sick, and personal days.
• 8 paid holidays.
• Remote work environment.
• Opportunity to lead organization-wide quality initiatives and influence clinical research standards across multiple sites.