Senior Director, Project Quality

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Director, Project Quality based in the United States.

This is a senior leadership opportunity focused on strengthening project quality and regulatory compliance across a multi-site clinical research organization.
You will serve as a subject matter expert and strategic partner across quality management, risk mitigation, and operational improvement initiatives.
The role will lead the development and ongoing management of a company-wide Quality Management System and electronic QMS.
You will build and guide a Project Quality team while partnering closely with site leaders, operations, and support functions.
Your expertise will help protect patient safety, maintain data integrity, and ensure consistent adherence to GCP, GxP, FDA requirements, and internal standards.
You will also play a key role in sponsor audits, regulatory inspections, CAPA management, quality metrics, and continuous improvement.
This role is well suited to an experienced clinical research quality leader who can influence at scale while fostering collaboration and operational excellence.

Accountabilities

• 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.
• Ability 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.
• Parental leave.
• 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.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

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We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.