Clinical QA Manager — Regulatory & Study Quality (Hybrid)

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

Benefits offered by this job

Hybrid work option

Remote-friendly

Job summary

Mass General Brigham seeks a Quality Assurance Manager to lead regulatory and QA activities within the NCRI. The role reports to senior QA leadership and supports audits, SOP updates, and risk-based CAPAs across multiple clinical studies.

You will audit trials, review TMFs, and collaborate with investigators, study teams, and sponsors to maintain strict quality standards in FDA-regulated environments. Hybrid/remote work is available.

Qualifications

• Bachelor's degree in a scientific, healthcare, clinical research, quality, regulatory, or related discipline is required.
• 3+ years of clinical research or QA experience; supervisory experience preferred.
• Strong knowledge of regulatory guidelines (FDA, ICH, GCP) and QA processes.
• Demonstrated ability to manage audits, CAPAs and SOP updates.

Responsibilities

• Implement NCRI QA plans and ensure adherence to GCP and regulatory policies.
• Lead internal/external audits and draft audit reports with findings.
• Develop, revise and train on SOPs to improve QA processes.
• Collaborate with study teams, sponsors and leadership to drive QA improvements.

Skills

Time management

Leadership

Communication skills

GCP knowledge

Budget management

Clinical research

Education

Bachelor's degree in scientific/healthcare field

Master's degree preferred

Tools

Microsoft Office

Job description

Mass General Brigham seeks a Quality Assurance Manager to lead regulatory and QA activities within the NCRI. The role reports to senior QA leadership and supports audits, SOP updates, and risk-based CAPAs across multiple clinical studies.

You will audit trials, review TMFs, and collaborate with investigators, study teams, and sponsors to maintain strict quality standards in FDA-regulated environments. Hybrid/remote work is available.