Quality Assurance Manager

Mass General Brigham•Somerville, MA

5d•Hybrid

About The Position

The Quality Assurance Manager (QAM) works within the Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital, an academic research organization managing clinical research in neurological disorders. The QAM focuses on regulatory and quality assurance aspects of clinical research and implements quality initiatives in the NCRI Quality Management Plan. The role ensures research is conducted in accordance with the plan, applicable regulations, good clinical practice guidelines, and institutional policies and procedures. The QAM audits clinical research projects coordinated by NCRI and supports the Director of QA during regulatory agency and industry sponsor inspections and audits. Working under the supervision of a Senior Quality Assurance Manager and with general direction from a QAM II, the QAM conducts site audits and internal reviews, prepares audit reports, assists with responses to findings, and drafts and revises policies and standard operating procedures. The role also supports deviation management, Trial Master File quality, risk reviews, root cause analyses, corrective and preventive action plans, and inspection-readiness improvements. The QAM advises NCRI staff on regulatory compliance and good clinical practices and collaborates with NCRI study teams, functional teams, leadership, sponsors, and vendors. The position is hybrid or potentially remote, with reliable internet access required. Occasional onsite attendance and travel within the United States may be required for meetings, sponsor audits, regulatory inspections, or investigational site audits. The position is regular, full-time, and scheduled for 40 hours per week on the day shift. The listed annual pay range is $63,252.80–$102,596.00.

Requirements

Bachelor's degree in a scientific, healthcare, clinical research, quality, regulatory, or related discipline; experience cannot substitute for a degree.
At least three years of working experience related to clinical research, academic research, quality assurance, or a similar environment.
Strong understanding of clinical research methodology and regulations, including FDA, OHRP, and ICH guidance and regulations, and the ability to advise study teams on their implementation.
Strong time-management and organizational skills.
Excellent leadership and written and verbal communication skills.
Ability to identify problems and develop potential solutions.
Excellent computer skills, including Microsoft Office.
Ability to work independently and as part of a team in a fast-moving, deadline-driven environment while balancing multiple tasks.
Ability to make independent, effective decisions.
Ability to develop and manage positive relationships with sponsor representatives, study team members, and vendors.
Reliable access to the internet.

Nice To Haves

Master's degree in a related field.
One to two years of prior supervisory experience.
Background or familiarity with biology or another scientific discipline.
Quality assurance experience in a clinical research setting.

Responsibilities

Implement assigned tasks in the NCRI Quality Management Plan, including its quality assurance functions, objectives, tracking processes, action plans, and goals.
Prepare for and participate in external NCRI audits and inspections conducted by regulatory authorities and industry sponsors.
Assist with drafting responses to findings from external auditors.
Conduct onsite and remote site audits and draft audit reports with observations and follow-up action items.
Review NCRI staff adherence to written policies and procedures.
Review assigned project documents—including protocols, Trial Master File plans, training plans, and quality management plans—for compliance with institutional policies and procedures, good clinical practice, and regulations.
Revise NCRI policies and standard operating procedures.
Participate in system-level and protocol-level deviation management.
Collaborate with study teams to build, maintain, and audit Trial Master Files.
Develop and implement risk review programs for assigned projects.
Conduct root cause analyses, implement corrective and preventive action plans, and perform effectiveness checks.
Collaborate with functional teams on process improvements and inspection readiness following internal reviews and external audits or inspections.
Communicate effectively with NCRI ARO leadership and sponsors.
Provide NCRI staff with guidance and advice on regulatory compliance and good clinical practices.
Accept and perform special projects as requested.
Travel as needed, including occasional travel within the United States to audit investigational sites.