Director, NCRI Quality Assurance/Regulatory Affairs

Mass General Brigham • Somerville, MA

6d • $124,342 - $180,898 • Hybrid

About The Position

The Director of NCRI Quality Assurance and Regulatory Affairs leads the development, implementation, and maintenance of a comprehensive quality assurance and regulatory compliance program for the MGH NCRI, supporting clinical trials conducted under FDA and institutional requirements. The role provides regulatory guidance, oversees audits and inspection readiness, develops quality tools and processes, and reports deficiencies and corrective action plans to NCRI leadership. The Director contributes to NCRI’s organizational direction and coordinates the effective use of personnel, fiscal, and material resources.

As a member of the NCRI leadership team, the Director leads the QA team’s operations and has direct management responsibility for approximately 10 staff. The role works with investigators, study teams, operational leaders, regulators, vendors, and other collaborators to promote compliant, ethical, and high-quality clinical research. The position is hybrid, based at 399 Revolution Drive, and is scheduled for 40 hours per week on the day shift.

Requirements

• Bachelor’s degree in a related field or scientific discipline required; a master’s degree in a related field is preferred. Experience cannot substitute for the degree.
• 8–10+ years of clinical research experience, including direct experience in quality assurance, auditing, and/or regulatory affairs in a healthcare setting.
• 5–7 years of experience in a management or leadership role.
• Comprehensive knowledge of healthcare regulatory compliance standards, accreditation processes, GxP regulations, FDA regulations, and ICH/GCP guidelines.
• Ability to interpret and appropriately implement regulations and advise clinical study teams.
• Strong analytical skills to conduct audits and risk assessments and interpret complex regulations.
• Ability to develop quality assurance strategies, compliance programs, and detailed corrective and preventive action plans, and ensure timely implementation.
• Leadership, communication, presentation, and writing skills, with the ability to collaborate effectively with diverse teams and stakeholders.
• Ability to work independently with minimal supervision and develop and manage positive working relationships.
• Strong attention to detail, organizational skills, and ability to manage multiple projects simultaneously.
• Ability to manage personnel and fiscal resources and supervise a QA team of approximately 10 staff.

Nice To Haves

• Significant experience working specifically in clinical research quality, supporting clinical trial compliance and management activities.
• Master’s degree in a related field.

Responsibilities

• Lead the development, implementation, evaluation, and administration of quality assurance processes and a strategic quality assurance plan across the NCRI.
• Develop tools and performance measures to monitor, track, and report quality results to NCRI and study leadership.
• Develop, implement, maintain, and train staff on clinical research quality standard operating procedures.
• Ensure compliance with federal, state, FDA, ICH/GCP, institutional, and accreditation requirements, including continuous monitoring and inspection readiness.
• Serve as the primary point of contact for external audits by sponsors and regulatory authorities, lead inspection-readiness activities, and draft responses to audit and inspection findings.
• Conduct and oversee audits of clinical trials, vendors, internal systems, and clinical sites, including remote and on-site audits as needed.
• Conduct investigations of GCP-related issues, identify root causes and systemic gaps, and develop corrective and preventive action plans; support study teams in completing actions on time.
• Review employee training files for completeness, document deficiencies, and coordinate quality assurance training and initiatives for NCRI staff and outside collaborators as needed.
• Provide regulatory guidance to cross-functional teams and advise on current regulations, best practices, risk-based management, contractual obligations, and compliant operations.
• Review regulatory and clinical documents for quality, accuracy, and internal consistency, including clinical trial agreements, clinical study reports, IND applications and annual reports, and DSMB reports.
• Administer and maintain quality management systems for change management, deviation management, document control, records management, and GCP training.
• Collaborate with cIRB to review and revise IRB submission processes, as applicable, and develop a pharmacovigilance program to monitor clinical trial safety.
• Oversee contracted vendor activities, including external monitors, central laboratories, drug depots, auditors, and safety oversight.
• Direct NCRI QA team operations and manage personnel and fiscal resources, including supervising staff, assigning and prioritizing work, ensuring adequate staffing, assessing competency, completing annual evaluations, approving Earned Time, and implementing corrective action when needed.
• Build and maintain productive relationships with staff, management, regulators, government agency personnel, and other relevant parties; attend cross-functional meetings and contribute to NCRI leadership.
• Accept special projects and perform other duties as assigned.

Benefits

• Competitive base pay
• Comprehensive benefits
• Career advancement opportunities
• Differentials, premiums, and bonuses as applicable
• Recognition programs
• Reasonable accommodations during the application or interview process and in performing essential job functions

What This Job Offers

• Job Type: Full-time
• Career Level: Director