Director, QA & Regulatory Affairs - Clinical Research

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

Job summary

Mass General Brigham's NCRI unit seeks a Director of Quality Assurance and Regulatory Affairs to lead the organization’s QA programs across clinical trials, audits, and regulatory compliance. You will develop and implement QA strategies, supervise a team of 10+ staff, coordinate with regulators and sponsors, and ensure adherence to FDA and ICH-GCP guidelines.

The role requires 8–10+ years in clinical research QA with leadership experience and a bachelor’s degree in a scientific discipline, plus

Qualifications

• 8-10+ years in quality assurance/regulatory affairs in healthcare.
• Strong knowledge of GxP, FDA, ICH/GCP guidelines.
• Excellent communication and leadership abilities for cross-functional collaboration.
• Ability to develop and implement QA strategies and corrective actions.

Responsibilities

• Lead QA and regulatory affairs programs across NCRI and affiliated sites.
• Oversee internal audits, risk assessments, and regulatory investigations.
• Collaborate with leadership, investigators, sponsors, and regulators to ensure compliance.
• Develop and maintain QA documentation, training, and SOPs.

Skills

Leadership

Regulatory knowledge

Audits

Communication

Project management

Detail-oriented

Education

Bachelor's degree in science

Master's degree preferred

Job description

Mass General Brigham's NCRI unit seeks a Director of Quality Assurance and Regulatory Affairs to lead the organization’s QA programs across clinical trials, audits, and regulatory compliance. You will develop and implement QA strategies, supervise a team of 10+ staff, coordinate with regulators and sponsors, and ensure adherence to FDA and ICH-GCP guidelines.

The role requires 8–10+ years in clinical research QA with leadership experience and a bachelor’s degree in a scientific discipline, plus