Clinical QA Manager – Regulatory & Audit Leader

Mass General Brigham; Somerville (MA); Hybrid; USD 63,000 - 103,000; Full time

Job summary

Mass General Brigham is seeking a Quality Assurance Manager for the Neurological Clinical Research Institute (NCRI) at 399 Revolution Drive, Boston. This role directs QA activities across clinical studies, ensuring adherence to GCP, regulations, and the NCRI Quality Management Plan.

Under supervision of Senior QA leadership, the QAM implements QA initiatives, conducts audits, drafts SOPs, and supports inspections.

Qualifications

• Bachelor's degree in a scientific, healthcare, clinical research, quality, regulatory, or related discipline.
• Three years of working experience in clinical research, academic research, quality assurance, or a similar environment.
• Preferred: background in biology or a related scientific discipline; QA experience in clinical research.

Responsibilities

• Collaborate with investigators and sites to meet startup, activation, and enrollment targets.
• Provide safety management oversight and regulatory reporting to FDA and boards.
• Audit and review regulatory documents; support QA initiatives per QMP.
• Assist with external audits and prepare audit responses.
• Draft, revise policies and SOPs; improve processes with NCRI teams.

Skills

Organizational skills

Communication skills

Analytical skills

Staff supervision

Database management

Budget management

Education

Bachelor's degree in a related field

Master's degree preferred

Tools

Microsoft Office

Job description

Mass General Brigham is seeking a Quality Assurance Manager for the Neurological Clinical Research Institute (NCRI) at 399 Revolution Drive, Boston. This role directs QA activities across clinical studies, ensuring adherence to GCP, regulations, and the NCRI Quality Management Plan.

Under supervision of Senior QA leadership, the QAM implements QA initiatives, conducts audits, drafts SOPs, and supports inspections.