Manager Quality Management
Job Locations
US-MI-Grand Rapids | US-IL-Aurora | US-IN-Indianapolis | US-WI-Milwaukee
ID
2024-10208
Category
Quality
Position Type
Full Time
Overview
Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive.
Position Summary
The Manager, Quality Management Systems role participates in the planning and execution of high-level quality operations, with a primary responsibility to oversee complex quality projects, systems, strategies, etc. (which may include, but are not limited to reviewing and approving policies and procedures; validations, software in support of quality activities, assisting in planning; approving deviations; approving corrective and preventative actions and change control; and performing subject matter expert functions). This role may act as the delegate for higher level Quality functions as described and assigned under job responsibilities. The manager is responsible for supervising assigned direct reports, performing personnel performance evaluations, and is involved in hiring and termination decisions within the Quality organization.
Responsibilities
Core Quality Responsibilities * Establishes and promotes a work environment that supports compliance to the Quality Policy and Quality Plan and documented quality processes and procedures. * Provides direction, coaching, and mentoring to team personnel to achieve organizational goals. * Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews. * Support quality improvement projects identified and developed by Quality personnel. * Fosters and sustains a culture of continuous improvement practices, including leading a team of employees in the identification and implementation into quality systems/assurance, compliance, regulatory affairs and/or education and improvement activities. * Oversee operations of the sub-organization for which he/she/they are responsible and provides direction, when necessary. * Leads internal/external assessments and facilitates optimal communication between the department and the investigator/inspector/assessors. * Provides resources for the actions identified based on quality metrics. * Identify and develop quality improvements. * Reviews and approves standard operating procedures, validation plans and results, corrective action plans associated with audits and events, and other required documents for compliance as required. * Champions strategies and actions identified based on quality metrics. * Supports execution of the Quality Management System
Specific Manager, Quality Management Systems Responsibilities * Responsible for the development and maintenance of the Quality Management System elements for Versiti, including but not limited to document and change management, events management, records management, change control, validation * Establishes and promotes a work environment that supports compliance to the Quality Policy and documented quality processes and procedures * Manages the quality personnel who perform the day-to-day implementation of the QMS * Fosters and sustains a culture of continuous improvement, including leading a team of employees in the identification and implementation of changes to systems and processes that result in operation efficiencies and improved customer outcomes * Assists direct/in-direct reports and internal customers in interpreting Quality System and product information control procedures * Develop goals/objectives for all assigned personnel. Monitor employees' performance against goals, provide performance feedback. Write and conduct development plans / performance appraisals * Leads and champions the work and communication between functional departments to assist in resolving issues * Provides leadership of the team responsible for ongoing maintenance of enterprise quality management software. Acts as subject matter expert for enterprise quality management software. * Leads quality systems improvements across the organization. * Analyzes, tracks, and trends resulting quality data to ensure proactive response to issues that may arise with enterprise quality management software * Develops and/or reviews documentation necessary to communicate quality policies, processes, and procedures across the organization. Assures controlled documentation is reviewed, approved, and published in accordance with the document control and change management quality systems. * Integrates continuous improvement practices adopted by Versiti into quality systems, education, and improvement activities. * May support or perform internal audits, analyze... For full info follow application link.
We embrace and encourage diversity in our workforce.
Equal Opportunity Employer of Minorities, Females, Protected Veterans, and Individuals with Disabilities.
We participate in eVerify.
We maintain a drug-free workplace and perform pre-employment substance abuse testing.
We are a tobacco/smoke-free workplace.
