Quality Assurance/Quality Improvement Manager - Full Time

Quality Assurance/Quality Improvement Manager - Full Time Holy Name Medical Center - 3.9 Teaneck, NJ Job Details Full-time $83,990.40 - $104,998.40 a year 1 day ago Benefits Free parking Health insurance Dental insurance Flexible spending account Tuition reimbursement Paid time off Vision insurance 401(k) matching Life insurance Childcare Qualifications Quality control corrective actions Performance dashboard reports Regulatory inspections Dashboard development Record keeping Document review (document control) Management Research ethical considerations Procedural guides 5 years Compliance audits & assessments Data reporting Corrective and preventive actions (CAPA) Risk mitigation strategy implementation Improving operational efficiency Patient safety Data quality management Quality assurance audits Clinical staff training Policy & process development Bachelor's degree Decision making Staff training Research compliance clinical trial records management Document archiving Overseeing audit functions Research regulatory compliance Continuous quality improvement (CQI) IRB compliance Root cause analysis Senior level Documentation review Communication skills FDA regulations Educational program management Staff development Full Job Description Description Welcome to Holy Name, a medical center where innovation is not just a goal — it's a commitment. Here, medical excellence thrives, allowing hope to reign supreme and leaving no room for fear. At our hospital, every patient is cared for with undivided attention — because healing every soul is our sole focus. Holy Name is New Jersey's only independent Catholic health system, comprising a 361-bed acute care hospital, a renowned cancer center, a state-of-the-art fitness center, a residential hospice, a prestigious nursing school, and an extensive physician network. Healing at Holy Name goes beyond medicine and technology - it is infused with faith, conviction, compassion, and a commitment to educating the next generation of healthcare professionals through a variety of residency and educational programs. Our mission to provide care for the body, mind, and soul spans education, prevention, diagnosis, treatment, rehabilitation, and overall wellness. This is at the core of who we are and what we do, and we've done it this way across generations, every single day, for nearly 100 years. Every innovation, medical breakthrough, and groundbreaking treatment is powered by some of the best minds in medicine, ensuring nothing is left on the table or the road to recovery. A Brief Overview The QA/QI Manager is responsible for overseeing quality assurance and quality improvement activities within the Institute for Clinical Research (ICR). This role ensures regulatory compliance, inspection readiness, and adherence to institutional, sponsor, FDA, and IRB requirements across all active studies. The QA/QI Manager leads internal audits, manages corrective and preventive action (CAPA) processes, monitors SOP compliance, and promotes a culture of continuous quality improvement to safeguard patient safety, data integrity, and institutional reputation. In this role, the QA/QI Manager is expected to deliver a structured and sustainable quality framework that includes routine risk-based internal audits, timely identification and remediation of compliance gaps, development and tracking of CAPAs, maintenance of training documentation, and preparation for sponsor, FDA, or external inspections. The position requires proactive monitoring of regulatory files and study conduct, trending of audit findings to identify systemic issues, and close collaboration with investigators and study teams to ensure operational excellence and continuous improvement across the research portfolio. A key deliverable of this role is an annual QA/QI Workplan that outlines prioritized quality initiatives, defines measurable objectives and audit schedules, assigns clear ownership, and establishes timelines and reporting mechanisms to ensure ongoing regulatory compliance, operational integrity, and continuous process improvement across the clinical research portfolio. What you will do

Education & Training:

Educates new research staff, including physicians, about QA/QI systems and requirements Tracks and reports training requirements for ICR staff (GCP, CITI, others) Disseminates current and newly updated information and provides guidance regarding compliance with Federal regulations, sponsoring agency, Holy Name policies and procedures. Coordinates with the ICR Human Subjects Protection Program (HSPP) to develop and implement educational programs and tools to effectively train researchers and staff participating in human research and related activities. Recommends education and process enhancements that will raise performance standards related to the conduct of research involving humans. Monitoring Working with the ICR Directors, Develops, disseminate and maintains QA/QI policies and SOPs Develops and executes annual QA/QI work plan Selects open human research protocols for monitoring based on risk assessment. Monitors open human research protocols and related activities to assure that human research is conducted and administered in accordance with Federal regulations, sponsoring agency and Holy Name policies and procedures, and protocols approved by internal & external IRBs Reviews informed consent procedure to assure that research participants are informed appropriately and in accordance with with Federal regulations and University and sponsoring agency policies and procedures. Reviews on-site record keeping to verify adherence to Federal regulations, sponsoring agency and Holy Name policies and procedures Meets with internal and external audiences to identify and problem solve QI issues Performs for-cause and not-for-cause audits of clinical research procedures to ensure compliance with internal and external QI standards. Reviews medical records and other documentation to ensure quality care. Coordinates with the ICR Executive Director to identify appropriate corrective actions for human participant research that is not being conducted in accordance with HSPP requirements, Federal regulations, sponsoring agency and Holy Name policies and procedures. Develops corrective action plans to address inconsistencies or flaws discovered during the audit procedure. Coordinates with the Principal Investigator and department administrator to implement corrective actions. Develops corrective action plans to address inconsistencies or flaws discovered during the audit procedure. Coordinates with the Principal Investigator and department administrator to implement corrective actions. Develops and maintains a Risk-Based Quality Management framework. Conducts site-level risk assessments for new protocols. Identifies high-risk therapeutic areas or investigators. Implements preventive controls before audit findings occur. Reviews sponsor and CRO monitoring reports for trends. Tracks sponsor-identified findings across studies. Identifies systemic issues across multiple protocols. Participates in sponsor qualification visits and feasibility assessments. Oversees version control of SOPs. Maintains QA document archive. Conducts periodic SOP review cycles. Ensures regulatory binders meet sponsor and FDA standards. Noncompliance Supports and endorses cooperation with Holy Name compliance efforts and reports instances of noncompliance to the appropriate institutional designees Maintains centralized deviation log across all industry trials. Tracks protocol deviations and serious noncompliance trends. Develops standardized CAPA tracking system. Performs effectiveness checks on corrective actions.

Inspection Readiness:

Leads site-level FDA, sponsor, CRO, and regulatory inspections. Develops and maintains inspection-readiness binder and documentation systems. Conducts mock inspections. Serves as primary liaison during regulatory inspections. Tracks inspection findings and ensures timely CAPA implementation.

Records and Reporting:

Reviews evidence of noncompliance identified during monitoring and reports findings to institutional officials and oversight entities in accordance with Federal regulations, sponsoring agency and Holy Name policies and procedures. Develops and tracks QA/QI metrics (e.g., deviation rate, consent errors, query resolution timelines). Reports trends quarterly to Executive Director/Medical Director. Develops dashboards for executive oversight. Conducts root cause analysis for recurring findings. Computer Systems /

Data Integrity Oversight:

Ensures data integrity and ALCOA+ compliance. Reviews access controls for EDC, CTMS, eReg systems. Audits electronic source documentation practices. Oversees Part 11 compliance where applicable. Education Qualifications Bachelor's Degree Sciences or related field required: Equivalent experience required Experience Qualification 5 years' experience in research or clinical setting required Knowledge, Skills, and Abilities Strong written and verbal communication skills SOP development and document control Data integrity and ALCOA+ principles Quality metrics analysis and reporting Independent judgment and ethical decision-making Ability to educate and influence investigators and research staff Licenses and Certifications GCP certification Upon Hire required At Holy Name, we believe in rewarding every team member with more than a paycheck—we invest in your future and well-being. Full-time and part-time employees have access to a comprehensive benefits package designed to support your health, financial security, and quality of life. We offer low-cost medical coverage with generous employer contributions, dental and vision plans, discounted prescriptions, and access to on-site child care. Additional benefits include 401(k) matching, tuition reimbursement, paid time off, flexible spending accounts, legal and voluntary coverage options, life insurance, and free on-site parking. If you are hired at Holy Name, your final base compensation will be determined based on factors such as employment status (Full/Part-Time or Per Diem) skills, education, and/or experience. In addition to those factors - we believe in the importance of pay equity and consider any internal equity of our current team members as a part of any final offer.

Pay Range:

$83,990.40 - $104,998.40 Holy Name is a mission-driven facility whose quality standards and philosophy are rooted in the principles of its founders, the Sisters of St. Joseph of Peace. Those principles are exercised daily by the Medical Center's dedicated and talented staff members. Holy Name is an Equal Opportunity Employer.