Quality Assurance Manager

Quality Assurance Manager 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 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 Neurological Clinical Research Institute 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 include: Implement specific tasks as outlined in the NCRI Quality Management Plan. 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. Review project-related documents to ensure adherence with institutional policies and procedures, GCP, and regulations. 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 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. Skills/abilities/competencies required include: 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 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.

Scheduled Weekly Hours: 40 Employee Type: Regular Work Shift: Day (United States of America)