Director, NCRI Quality Assurance/Regulatory Affairs

Mass General Brigham•Somerville, MA

5d•Hybrid

About The Position

The Director of NCRI Quality Assurance and Regulatory Affairs leads a comprehensive quality assurance and regulatory compliance program for the MGH Neurological Clinical Research Institute (NCRI), supporting clinical trials conducted under FDA and institutional regulations. The Director develops and maintains quality strategies, processes, tools, standard operating procedures, and training programs; audits clinical trials, sites, vendors, systems, and training files; and identifies deficiencies and drives timely corrective and preventive action. The role provides regulatory guidance to study teams and leadership, leads inspection-readiness activities, serves as the primary contact for external audits and regulatory inspections, and reviews clinical and regulatory documents for quality, accuracy, and consistency. The Director also oversees quality management systems and vendor activities, coordinates staff training and quality initiatives, and helps guide NCRI’s clinical research mission. As a member of the NCRI leadership team, the Director contributes to organizational direction and coordinates with NCRI leadership to use personnel, fiscal, and material resources effectively. The position directs the NCRI QA team, with full line responsibility for personnel and fiscal resources and direct supervision of approximately 10 team members. Duties include overseeing staff performance, workload, staffing, training, competency assessment, and adherence to regulatory and hospital requirements. The Director communicates with principal investigators, project managers, data and systems managers, regulators, government agency personnel, vendors, and other internal and external stakeholders.

Requirements

Bachelor’s degree in a related field; a scientific discipline is specified in the detailed qualifications. A master’s degree in a related field is preferred.
At least 8–10+ years of clinical research experience, including direct experience in quality assurance, auditing, and/or regulatory affairs in a healthcare or clinical research setting.
At least 5–7 years of management or leadership experience.
In-depth understanding of ICH Good Clinical Practice guidelines and relevant FDA regulations, with the ability to apply them and advise study teams.
Comprehensive knowledge of regulatory compliance standards, healthcare accreditation processes, and GxP regulations.
Ability to conduct audits and risk assessments, interpret complex regulations, identify root causes, and develop detailed corrective and preventive action plans and follow up on their implementation.
Ability to develop and implement quality assurance strategies, programs, and processes.
Leadership, communication, presentation, and writing skills, including the ability to work effectively with interdisciplinary teams and stakeholders.
Ability to work independently with minimal supervision and develop and manage positive working relationships.
Strong organizational and analytical skills, attention to detail, and ability to manage multiple projects simultaneously.
Ability to direct a team and manage personnel and fiscal resources.

Nice To Haves

Master’s degree in a related field.
Significant experience in clinical research quality, supporting clinical trial compliance and management activities.

Responsibilities

Lead the development, implementation, evaluation, and administration of NCRI quality assurance processes and strategic plans, including objectives, tracking processes, action plans, goals, and priorities.
Develop tools to monitor and report quality performance measures and results to NCRI leadership and study teams.
Develop, implement, maintain, and train staff on standard operating procedures specific to clinical research quality.
Serve as the primary contact for external sponsor and regulatory authority audits; prepare responses to audit and inspection findings and lead inspection-readiness activities.
Advise operational leaders and staff on regulatory requirements, contractual obligations, and compliant, lawful, and ethical practices.
Build productive relationships with management, staff, regulators, government agency personnel, and other relevant parties.
Attend cross-functional meetings and advise teams on current regulations and best practices, including risk-based management.
Identify systemic gaps and coordinate timely remediation with appropriate stakeholders.
Audit vendors, internal systems, clinical sites, and trials managed by MGH NCRI; investigate GCP-related issues, identify root causes, and develop corrective and preventive action plans.
Review MGH NCRI employee training files for completeness and report deficiencies to NCRI leadership.
Assist study teams in implementing action plans and ensure objectives are completed in a timely manner.
Coordinate quality assurance initiatives and training sessions for MGH NCRI staff and outside collaborators as needed.
Review regulatory and clinical documents for quality, accuracy, and internal consistency, including clinical trial agreements, clinical study reports, IND applications and annual reports, and DSMB reports.
Administer and maintain quality management systems, including change management, deviation management, document control, records management, and GCP training management.
Collaborate with cIRB to review and revise IRB submission processes, as applicable.
Develop a pharmacovigilance program to monitor safety in clinical trials.
Oversee NCRI-contracted vendors, including external monitors, central laboratories, drug depots, auditors, and safety oversight providers.
Direct NCRI QA team operations and manage associated personnel and fiscal resources.
Supervise approximately 10 QA staff, including overseeing performance, assigning and prioritizing work, ensuring adequate staffing, scheduling and approving Earned Time, implementing corrective action, assessing competency, and completing annual evaluations.
Meet regularly with NCRI QA staff to organize and prioritize work, and supervise training for new QA team hires.
Accept special projects and perform other duties as assigned.