Quality Assurance Manager

Mass General Brigham•Somerville, MA

3d•Hybrid

About The Position

Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. The Neurological Clinical Research Institute (NCRI) at the Massachusetts General Hospital (MGH) is a premier Academic Research Organization (ARO) managing clinical trials in neurological disorders. The NCRI employs physician clinical researchers, research nurses, project managers, data managers, SAS programmers, systems analysts, grants managers, research nurses, quality specialists, and administrative assistants dedicated to planning and implementing clinical trials. The Quality Assurance Clinical Trial Project Manager (QAM) will focus on regulatory and quality assurance aspects of clinical research. Receiving general direction from the NCRI Director Quality Assurance (QA) and 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 of NCRI by regulatory authorities and industry sponsors. Lead/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. Develop new/revise NCRI written procedures, such as policies and SOPs. In collaboration with Functional Teams, select and manage vendors contracted by NCRI. Assist with pre-qualification and periodic audits of vendors contracted by NCRI. 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. Develop and review corrective action and preventive action plans (CAPAs) and perform effectiveness checks. Collaborate with Functional Teams and QAM II on process improvement initiatives for inspection readiness following internal reviews, external audits/inspections, and have effective communication with NCRI ARO leadership and Sponsors. Act as a resource to NCRI staff and provide guidance/advice on regulatory compliance and good clinical practices, as needed. Accept responsibilities for special projects as requested.

Requirements

High level of time management and organizational skills.
Excellent leadership, written and verbal communication skills.
A solid understanding of clinical research methodology and regulations, including FDA, OHRP, and ICH guidelines and regulations related to the conduct of clinical research trials, and the ability to advise study teams on how best to implement these regulations.
Ability to identify problems and develop potential solutions.
Excellent computer skills working with Microsoft Office.
Team player who can work independently in an extremely fast-moving, deadline-driven environment, while balancing multiple tasks simultaneously.
Ability to make independent, effective decisions.
The ability to develop and manage positive relationships with sponsor representatives, study team members, and vendors.
Minimum of three (3) years of working experience related to clinical research, academic research, quality assurance, or a similar environment required.

Nice To Haves

Background/familiarity with biology or other scientific disciplines is preferred, but not required.
Experience with Quality Assurance in a clinical research setting is preferred, but not required.
Previous experience in quality auditing, both internal and external, is preferred, but not required.

Responsibilities

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 of NCRI by regulatory authorities and industry sponsors.
Lead/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.
Develop new/revise NCRI written procedures, such as policies and SOPs.
In collaboration with Functional Teams, select and manage vendors contracted by NCRI.
Assist with pre-qualification and periodic audits of vendors contracted by NCRI.
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.
Develop and review corrective action and preventive action plans (CAPAs) and perform effectiveness checks.
Collaborate with Functional Teams and QAM II on process improvement initiatives for inspection readiness following internal reviews, external audits/inspections, and have effective communication with NCRI ARO leadership and Sponsors.
Act as a resource to NCRI staff and provide guidance/advice on regulatory compliance and good clinical practices, as needed.
Accept responsibilities for special projects as requested.