Director, QA & Regulatory Affairs – Clinical Research

Mass General Brigham; Somerville (MA); Hybrid; USD 124,000 - 181,000; Full time

Job summary

Mass General Brigham NCRI seeks a Director of Quality Assurance and Regulatory Affairs to lead QA strategies, audits, and regulatory programs across clinical trials, ensuring FDA and ICH/GCP compliance.

You will oversee 10+ QA staff, coordinate with regulators and study teams, develop corrective action plans, and maintain training and SOPs, partnering with NCRI leadership to advance clinical neuroscience research.

Qualifications

• 8-10+ years of clinical research experience including direct experience in QA, auditing and/or Regulatory Affairs
• 5-7 years in a management or leadership role
• Extensive knowledge of GxP regulations, FDA, and ICH/GCP guidelines
• Minimum of a bachelor’s degree in a scientific discipline

Responsibilities

• Lead the development, implementation, and administration of QA programs and regulatory affairs for NCRI trials
• Oversee audits of NCRI SOPs and coordinate external sponsor/regulator inspections
• Manage QA staff and coordinate training, action plans, and corrective/preventive actions
• Review regulatory documents for accuracy and maintain Quality Management Systems

Skills

Leadership

Communication

GxP knowledge

Regulatory affairs

Auditing

Risk management

Education

Bachelor's degree in a scientific discipline

Tools

Quality Management Systems

Job description

Mass General Brigham NCRI seeks a Director of Quality Assurance and Regulatory Affairs to lead QA strategies, audits, and regulatory programs across clinical trials, ensuring FDA and ICH/GCP compliance.

You will oversee 10+ QA staff, coordinate with regulators and study teams, develop corrective action plans, and maintain training and SOPs, partnering with NCRI leadership to advance clinical neuroscience research.