Director, QA & Regulatory Affairs — NCRI Leadership (Hybrid)

Mass General Brigham; Somerville (MA); Híbrido; USD 124.000 - 181.000; Jornada completa

Descripción de la vacante

Mass General Brigham is seeking a Director of Quality Assurance and Regulatory Affairs to oversee QA programs and regulatory compliance across the organization, including audits, training, and liaison with regulators.

The role leads internal audits, risk assessments, and corrective actions, develops SOPs and QA tools for clinical research, and partners with NCRI leadership to advance compliant, high‑quality patient care.

Formación

• 8-10+ years of clinical research QA/regulatory affairs with management experience.
• Bachelor’s degree in a scientific field; master’s preferred.
• Strong knowledge of FDA, ICH/GCP, and GxP regulations.
• Experience leading audits, investigations, and corrective actions.
• Excellent communication and leadership abilities.

Responsabilidades

• Oversee QA processes across the organization and ensure regulatory compliance.
• Lead internal audits, risk assessments, and corrective actions.
• Develop and maintain QA programs and SOPs for clinical trials.
• Coordinate with NCRI and regulators; prepare reports.
• Train staff on regulatory requirements and QA best practices.

Conocimientos

Regulatory compliance

Quality assurance

Audits & risk assessments

Leadership

Communication

Detail-oriented

Educación

Bachelor’s degree in a scientific field

Master’s degree preferred

Descripción del empleo

Mass General Brigham is seeking a Director of Quality Assurance and Regulatory Affairs to oversee QA programs and regulatory compliance across the organization, including audits, training, and liaison with regulators.

The role leads internal audits, risk assessments, and corrective actions, develops SOPs and QA tools for clinical research, and partners with NCRI leadership to advance compliant, high‑quality patient care.