Quality Manager - Transplant Lab, Full-Time, Days

Northwestern Memorial Healthcare•Chicago, IL

2d•$52 - $75

About The Position

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.

Requirements

A bachelor’s degree in a laboratory science or equivalent, such as medical technology/clinical laboratory science, biology, microbiology, molecular biology, chemistry, and biochemistry
Previous work experience in the field of cellular therapy product processing
Knowledge of FDA, FACT, ISO, NMDP. IDOT, CMS, CLIA, JCAHO and NCCLS Standards
Knowledge and experience with cGMP manufacturing, quality, and compliance as well as US and global cGMP requirement

Nice To Haves

(ASCP) certification
Experience with quality systems

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 recommending improvements in process and workflow for laboratory sections.
Assures that responses to audits, both internal and external, are well documented.
Authors and revises, as needed, departmental SOPs related to compliance, quality and laboratory general policies. Reviews and documents review of laboratory and departmental SOPs for compliance with regulatory standards and internal policies.
Reviews and approves SOPs, protocols, reports, and production batch records
Assures that research activities performed in the department are in compliance with Hospital Research policies.
Maintains departmental quality, accreditation and regulatory records.
Develops and maintains a higher level of expertise in the specific areas of responsibility.
Participates in and presents at laboratory meetings and continuing education programs.
Participates in hospital quality and safety meetings as assigned.
Participates in business planning meetings.
Assign and manage Quality Assurance Specialist tasks and daily activities.
Adheres to Patients First Management standards on leadership, communication and visibility.
Coordinates critical situations involving patients, staff, and visitors and consults with manager or administrator for guidance as needed (e.g., complaints, discipline, the press, etc.).
Facilitates effective interdepartmental communication of incidents with appropriate personnel (Manager, Administrator, Medical Staff; etc.).
Promotes philosophy and objectives of the Hospital, Division and Department.
Identifies and communicates key issues and trends to manager.
Establishes and executes personal development objectives as part of annual objective setting process that complements current position.
Participate in continued education activities to meet the minimum requirement from the regulatory body
Identifies and pursues activities/development opportunities that are appropriate for position and personal development objectives, e.g., participation/leadership in relevant professional groups associations, continuing education as participant, presenter, and planner.
Assesses and communicates staff development needs to Laboratory Director