Quality Manager - Transplant Lab, Full-Time, Days

Company Description

At Northwestern Medicine, every patient interaction makes a difference in cultivating a positive workplace. This patient-first approach is what sets us apart as a leader in the healthcare industry. As an integral part of our team, you'll have the opportunity to join our quest for better health care, no matter where you work within the Northwestern Medicine system. We pride ourselves on providing competitive benefits: from tuition reimbursement and loan forgiveness to 401(k) matching and lifecycle benefits, our goal is to take care of our employees. Ready to join our quest for better?

Job Description

The Quality Manager reflects the mission, vision, and values of NM, adheres to the organization’s Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation standards.

The Quality Manager works with the Cell Therapy Laboratory Director and the Laboratory Manager to assure regulatory compliance of department activities. This role provides consultation to other internal and contracted external hospital departments and committees regarding regulatory requirements in the Cell Therapy Laboratory.

The Quality Manager will have experience in evaluating, implementing and maintaining quality processes. This individual must have excellent written and oral communication skills and proven ability to work independently with minimal supervision. The ideal candidate must be detail oriented and able to successfully interface directly with cross-functional teams. Individual must have the ability to develop, review and maintain metrics and perform quality audits. The position requires proficiency with MS office applications as well as internet/intranet use. The variable nature of the work performed requires demonstrated problem-solving capabilities. The individual must possess high moral and ethical standards.

Responsibilities:

• Develops and maintains a Quality Management System (QMS) relative to the technical evaluation and improvement of services in relation to physician and patient care requirements
• Documents all significant activities and recommends corrective action and improvements, as necessary.
• Facilitates compliance with all federal, state, local, JCAHO, FACT, ISO, NMDP, NCCLS, multi-disciplinary, hospital regulations, policies and procedures. Reports significant events to JCAHO, FDA and NM management and Medical Directors as required.
• Develops and maintains a current QMS Plan and current Standard Operating Procedures (SOPs), guidelines, standards and records.
• Facilitate and oversight of process development, validation, process improvements, and new procedure implementation.
• Responsible for controlling new and revised documents required for the operation of the QMS pursuant to the QMS Plan.
• Plans and facilitates departmental preparations for accreditation inspections. Responsible for inspections related to quality assurance, compliance and general laboratory policy and practice.
• Maintains a robust Quality Assurance Program that addresses batch disposition, deviation, investigation and corrective action.
• Reviews and manages departmental Incident Reports, Quality Improvement Reports and Critical Incident reports.  Prepares regular reports regarding tracking and trending of quality issues, and presents the findings to appropriate management personnel.
• Ensure accurate and complete data acquisition and integrity.
• Leads and manages the day to day activities of all quality assurance personnel and ensures the efficiency and effectiveness of all on-site quality system activities
• Provides assistance to senior staff in analysis and corrective action plan development in response to incidents.
• Serves as, or works in cooperation with, the department primary Safety and Emergency Management Officer, and/or the laboratory liaison with NM Safety department.
• Orients, trains and oversees activities of the departmental Safety Officers to ensure compliance with hospital and regulatory agency requirements.
• Provides training to departmental staff on quality, compliance and safety issues.
• Develops agendas and creates meeting minutes for department and hospital quality meetings.
• Establishes ongoing quality data collection, which enables monitoring of testing systems. 
• Maintains knowledge and utilizes appropriate resources to provide consultative, educational, technical, or informational services as needed to self, staff or patients.
• Manages departmental supply recalls in accordance with regulatory requirements.
• Develops and supervises departmental operation audits and communicates results to department management.
• Conducts internal audits.  Evaluates and prepares reports reco