Quality Assurance Manager

The General Hospital Corporation; Somerville (MA); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

The General Hospital Corporation, through the Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital, seeks a Quality Assurance Manager to drive QA initiatives for regulatory compliance, SOPs, and audits across multi-site clinical research programs.

You will work under supervision of senior QA leadership, coordinating with study teams, regulatory authorities, and industry sponsors to ensure study quality and compliance with GCP and institutional policies.

Formación

• Strong organizational and communication skills.
• Demonstrated analytical skills.
• Effective problem solving skills.
• Ability to supervise and train staff effectively.
• Strong database management and computer skills.
• Must possess aptitude for budget management.

Responsabilidades

• Audit NCRI projects for adherence to policies, SOPs and GCP.
• Coordinate QA activities with NCRI study teams and regulatory bodies.
• Prepare for external audits/inspections and respond to audit findings.
• Draft and revise NCRI policies and SOPs; ensure inspections readiness.
• Oversee QA tasks per the NCRI Quality Management Plan and CAPAs.
• Lead internal reviews of staff adherence and training effectiveness.

Conocimientos

Organizational skills

Communication skills

Analytical skills

Staff supervision

Database management

Budget management

Educación

Bachelor's Degree (related field)

Master's Degree (related field) preferred

Descripción del empleo

Site: The General Hospital Corporation

Job Summary

Summary

The position reports directly to the Sr Project Manager and/or Project Director of a large global clinical study. This position has management responsibility for specific roles within a clinical study assigned to support the day-to‑day operational project management of assigned trial(s).

Does this position require Patient Care?

No

Essential Functions

• Collaborating with project investigators and research sites to ensure targets are met for study start up, site activation, patient recruitment and enrollment.
• Safety management and reporting to FDA, Data and Safety Monitoring Boards, Medical Monitors, funding agencies and other regulatory bodies.
• Collecting, reviewing and approving of all required regulatory documents; and working to ensure the study Trial.
• Managing multi‑center trials funded by NIH, Industry standards.
• Collaborate with grants management team to prepare progress reports.
• Provide safety management oversight for studies, in collaboration with study PI and safety boards.

Qualifications

Education

Bachelor's Degree Related Field of Study required or Master's Degree Related Field of Study preferred

Can this role accept experience in lieu of a degree?

No

Experience

Progressively more responsible experience in a research related field 3-5 years required and Prior Supervisory Experience 1-2 years preferred

Knowledge, Skills and Abilities

• Strong organizational and communication skills.
• Demonstrated analytical skills.
• Effective problem solving skills.
• Ability to supervise and train staff effectively.
• Strong database management and computer skills.
• Must possess aptitude for budget management.

Additional Job Details (if applicable)

The Neurological Clinical Research Institute (NCRI), at Massachusetts General Hospital (MGH), is a premier Academic Research Organization (ARO) managing clinical research in neurological disorders. The NCRI employs multidisciplinary professionals dedicated to planning, implementation, oversight, and quality of clinical research.

The Quality Assurance Manager (QAM) will focus on regulatory and quality assurance aspects of clinical research. Under the supervision of a Senior Quality Assurance Manager, and provided with general direction by a QAM II, the QAM is responsible for implementing quality initiatives outlined in the NCRI Quality Management Plan (QMP) and ensuring NCRI staff are conducting research projects according to the QMP, regulations, good clinical practice guidelines and institutional policies and procedures.

The incumbent will audit clinical research projects coordinated by NCRI ARO. In addition, the QAM will support the Director of QA during inspections/audits of NCRI performed by regulatory agencies and industry sponsors. The QAM will perform internal reviews of NCRI staff adherence to written policies and procedures. The QAM will draft and revise NCRI policies and standard operating procedures (SOPs).

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Relevant activities include, but are not limited to the following:

Implement specific tasks as outlined in the NCRI Quality Management Plan, which defines QA functions, objectives, tracking processes, action plans, and identifies goals.

Prepare for and participate in external audits/inspections of NCRI by regulatory authorities and industry sponsors.

Assist with drafting responses to audit findings by external auditors.

Perform on‑site and remote site audits and draft audit reports with observations and follow‑up action items.

Perform internal reviews of NCRI staff adherence to written policies and procedures.

• For assigned projects, review project‑related documents to ensure adherence with institutional policies and procedures, GCP, and regulations, including protocols, trial master file plans, training plans, quality management plans etc.
• Revise NCRI written procedures such as policies and SOPs.
• Engage in deviation management activities at the system‑level and protocol‑level.
• Collaborate with NCRI study teams to build, maintain and audit Trial Master Files (TMF).
• For assigned projects, develop and implement a risk review program.
• Perform root cause analyses, implement corrective action and preventive action plans (CAPAs), and perform effectiveness checks.
• Collaborate with Functional Teams on process improvement initiatives for inspection readiness following internal reviews, external audits/inspections, and have effective commu