Title:  Lab Quality & Regulatory Program Manager | Lab - University | FT - Days Job

Summary

Responsible for managing the implementation and evaluation of system-wide Quality System Essentials for Laboratory Services. Develops standard policies, operating procedures, and validation plans. Reviews and ensures proper application of regulatory and accreditation standards to work processes. Works closely with facility operational leaders to achieve goals and objectives for laboratory services. Models appropriate behavior as exemplified in MLH Mission, Vision and Values. Models appropriate behavior as exemplified in MLH Mission, Vision and Values.

Education/Experience/Licensure

Knowledge/Skills/Abilities

• Strong knowledge of the cycle and properties of blood production and distribution methods and theories.
• Strong knowledge of regulatory and accreditation standards as they apply to Transfusion Medicine, Apheresis, and Laboratory Services.
• Demonstrated skills in technical writing with emphasis on creation of standard operating procedures.
• Good working knowledge of computers and software applications such as spreadsheets, word processing, and database applications. Basic knowledge of laboratory information systems.
• Demonstrated knowledge in the application of quality tools and methodologies.
• Demonstrates strong skills in analytical thinking, problem solving, and high attention to detail.
• Ability to effectively instruct others in technical and regulatory requirements.
• Ability to effectively relate and communicate with internal and external customers.
• Ability to organize tasks and projects and works independently to complete tasks.
• Will require travel to multiple MLH facilities; must have valid driver’s license and insurance.

Key Job Responsibilities

• Manages the implementation and evaluation of system-wide Quality System Essentials for Transfusion Service, Apheresis Services, and Laboratory Services.
• Identifies, coordinates and implements quality monitoring to ensure compliance with regulatory requirements, quality standards, compliance activities, and policies and procedures.
• Develops and recommends procedures to improve operational efficiency and quality of service.
• Performs quality audits, identifies inconsistencies, and recommends corrective actions for processes and procedures.
• Establishes and maintains efficient and reliable mechanisms for monitoring, analysis, and reporting of quality outcomes and performance improvement initiatives. Ensures the integration of aggregate data into performance improvement planning and problem resolution.
• Manages the development and standardization of policies, standard operating procedures, protocols and validation plans for the adult MLH transfusion services.
• Develops, composes, validates, publishes, and implements use of standard operating procedures for Transfusion Services, Apheresis Services and Laboratory Services.
• Communicates policy and procedure information and initiates appropriate changes to ensure compliance.
• Serves as System Administrator of the Transfusion Services and Apheresis Services document control system (WellSky) for the adult transfusion services of the MLH system.
• Responsible for review of regulatory (CAP, FDA, CLIA and CMS) and accreditation standards (AABB, CAP, FACT) applicable to Transfusion Services, Apheresis Services and other lab functions.
• Manages the review of regulatory and accreditation standards applicable to Transfusion Services, Apheresis Services and Laboratory Services.
• Regularly reviews regulatory standards and updates as assigned to ensure processes are performed at or above the applicable regulatory standards.
• Modifies, updates, and executes established programs to maintain compliance. Supports or leads projects for the timely completion of corrective actions.
• Identifies, recommends, and/or presents educational programs and materials to enhance the staff’s knowledge of accreditation and regulatory standards.
• Provides support for ongoing compliance and survey readiness with laboratory accrediting bodies and other applicable regulatory agencies.
• Coordinates clinical trials with principal investigators, study coordinators, quality assurance and compliance.
• Performs special projects including clinical trial involving cellular therapy products.

Physical Requirements

• The physical activities of this position may include climbing, pushing, standing, hearing, walking, reaching, grasping, kneeling, stooping, and repetitive motion.
• Must have good balance and coordination.
• The physical requirements of this position are: light work - exerting up to 25 lbs. of force occasionally and/or up to 10 lbs. of force frequently.
• The Associate is required to have close visual acuity to perform an activity, such as preparing and analyzing data and figures; transcribing; viewing a computer terminal; or extensive reading.
• The conditions to which the Associate will be subject in this position: The Associate is not substantially exposed to adverse environmental conditions; job functions are typically performed under conditions such as those found in general office or administrative work.