Director – Quality Assurance/Regulatory Affairs

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.

Job Summary

Summary
Responsible for overseeing quality assurance and regulatory affairs for the organization, ensuring compliance with healthcare regulations and accreditation standards. This role develops and implements quality assurance processes, monitors regulatory compliance, and collaborates with leadership to maintain a high standard of care.

Does this position require Patient Care?
No

Essential Functions
-Leads the development, implementation, and evaluation of quality assurance processes across the hospital.

-Ensures compliance with federal, state, and accreditation requirements, including continuous monitoring and audit readiness.

-Collaborates with hospital departments to identify, address, and resolve quality and compliance issues.

-Oversees the development and execution of regulatory affairs programs to ensure compliance with applicable standards.

-Leads internal audits, risk assessments, and compliance investigations, reporting findings to senior leadership.

-Develops corrective action plans and preventive measures to address compliance gaps and quality issues.

-Monitors and assesses the effectiveness of quality initiatives, making recommendations for process improvement.

-Serves as a liaison with regulatory agencies, preparing necessary reports and responding to inquiries.

-Trains and educates staff on regulatory requirements and quality assurance best practices to promote a culture of compliance.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 Licenses and Credentials Experience Experience in quality assurance, regulatory affairs or other closely related role in a healthcare setting 8-10+ years required and Experience in a management or leadership role 5-7 years required Knowledge, Skills and Abilities - Comprehensive knowledge of regulatory compliance standards and healthcare accreditation processes. - Strong analytical skills with the ability to conduct audits, risk assessments, and interpret complex regulations. - Exceptional communication and leadership abilities for effective collaboration with diverse teams and stakeholders. - Proven ability to develop and implement quality assurance strategies and compliance programs. - Detail-oriented, with strong organizational skills and the ability to manage multiple projects simultaneously.

Directors of the NCRI, the Director of Quality Assurance and Regulatory Affairs is responsible for developing, implementing, and maintaining a comprehensive and cohesive quality assurance program for the MGH NCRI to conduct clinical trials under FDA and institutional regulations. The incumbent will be responsible for performing audits of NCRI SOPs for clinical trials that we coordinate. The incumbent will be responsible for further developing tools for documenting and tracking staff training and auditing the training files of all MGH NCRI employees to ensure that they are complete, and that required

training is properly documented. He/she will generate reports to clearly document deficiencies and provide an action plan for improving compliance. The incumbent will provide remote and on-site auditing of clinical sites and vendors, as needed and be responsible for coordinating quality assurance initiatives for the MGH NCRI staff. The incumbent will also contribute

to the overall leadership and guidance of the entire NCRI towards achieving its mission to advance clinical neurological care through excellence in clinical research at both the coordination center and site level and to educate future research leaders in the field of neurology clinical research.

The Director of Quality Assurance and Regulatory Affairs must be able to communicate effectively with principal investigators, project managers, systems and data managers, and other members of the interdisciplinary team. He/she will provide regulatory compliance advice to members of the NCRI and is expected to create new ideas, decide on workflow, and

work distribution, and have a leadership role in the NCRI and the field. As a member of the NCRI organizational team, the Director of Quality Assurance and Regulatory Affairs shares the responsibility of providing the organizational direction necessary to effect change and promote excellence for the NCRI. The incumbent coordinates with NCRI leadership to ensure

effective and optimal utilization of personnel, fiscal, and material resources.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Principal Duties:

• Key Member of the NCRI Leadership team, representing the Quality Assurance and Regulatory (QA) team

• Develop, implement, and administer a strategic plan for overall quality assurance that defines objectives, tracking processes, action plans, and identifies goals and priorities.

• Develop tools to monitor and report performance measures and quality results to the Director of the NCRI, Sr. Director, and/or individual study teams, as appropriate.

• Develop, implement, maintain, and train on SOPs specific to clinical research quality.

• Serve as the primary point of contact for all NCRI external audits by sponsors and regulatory authorities, and draft responses to audit/inspection findings. Lead inspection readiness activities for NCRI cross-functional teams.

• Work with operational leadership to provide support and information to ensure that they and their employees gain the requisite knowledge of regulatory issues and requirements and contractual obligations to carry out their responsibilities in a compliant, lawful, and ethical manner.

• Develop and maintain productive relationships with all levels of management, staff, as well as regulators, government agency personnel, and other relevant parties.

• Attends cross-functional team meetings and provides guidance to the team based on interpretation of current

regulations to ensure best practices, including risk-based management.

• Identifies potential systemic gaps and coordinates with the appropriate stakeholders to ensure timely remediation.

• Audits vendors, internal systems, and clinical sites. Conducts investigations of GCP-related issues to identify root causes and creates corrective and preventative action plans.

• Periodically review training files for all MGH NCRI employees for completeness and report deficiencies to NCRI Leadership.

• Perform periodic quality assurance audits on trials managed by the MGH NCRI, to ensure completeness, report deficiencies, and propose detailed action plans for improving compliance to the Sr. Director and appropriate study team members.

• Assist study teams with implementation of action plans and ensure that all objectives are met within a timely manner.

• Coordinate quality assurance initiatives and training sessions for MGH NCRI staff.

• Assist with preparing and delivering training sessions for MGH NCRI staff as well as outside collaborators, as needed.

• Review regulatory and clinical documents for accuracy and internal consistency as it applies to quality (e.g., Clinical

Trial Agreements, Clinical Study Reports, IND applications, IND annual reports, DSMB reports, etc.).

• Administer and maintain various 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 the activities of vendors contracted by NCRI such as external monitors, central labs, drug depots, auditors, and safety oversight.

• Accept responsibility for special projects as requested.

• Performs all other duties as assigned.

Human Resources

• Directs the operations of the NCRI QA team. Has full line responsibility and accountability for management of

personnel and fiscal resources.

• Builds and maintains ongoing working relationships with staff to facilitate positive staff morale and to support

productivity through regular meetings.

• Responsible for daily supervision of 10+ QA staff

o Oversee day-to-day performance.

o Assign and prioritize workload.

o Ensure adequate staffing to meet NCRI needs.

o Schedule and approve Earned Time

o Implement corrective action as necessary.

o Assess staff competency and complete annual evaluation.

o Monitors staff adherence to regulatory requirements as well as hospital policies and procedures.

• Meets regularly with NCRI QA staff to organize and prioritize work processes.

• Supervises training for all new hires of the QA team.

SKILLS AND COMPETENCIES:

• Leadership skills, good presentation and writing skills are required.

• The ability to work independently with minimal supervision and to develop and manage positive relationships is required.

• An in-depth understanding of the principles of ICH Good Clinical Practice guidelines, relevant FDA regulations, and the ability to implement them appropriately and advise study teams on how best to implement them is required.

• The ability to develop detailed corrective and preventative action plans for improving compliance and following up to ensure that these plans are implemented in a timely manner is required.

EXPERIENCE:

Required:

• 8-10+ years of clinical research experience including direct experience in QA, auditing and/or Regulatory Affairs required and experience in a management or leadership role 5-7 years required

• Significant experience working specifically within clinical research quality (supporting clinical trial

compliance/management activities) preferred.

• Extensive knowledge of GxP regulations, FDA, and ICH/GCP guidelines

• Minimum of a bachelor’s degree in a scientific discipline

SUPERVISORY EXPERIENCE:
Direct: Direct reporting responsibility for ~10 team members providing regulatory adherence oversight, including the Pharmacovigilance, cIRB Liaison Team, and QA Team.

Indirect: Supervision of MGH NCRI staff on implementation of action plans, as needed.

Hybrid399 Revolution Drive40RegularDay (United States of America)

Pay Range

$124,342.40 - $180,897.60/Annual

Grade

9At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.

Mass General Brigham Competency Framework