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 processes and procedures, risk mitigation assessments, provide technical support promoting productivity improvements or cost reduction opportunities. Assess non-conformance / audit findings and lead closure of actions, as needed * Leads and supports the integration, upgrades, decommissions, etc. of the tools required to maintain an effective quality management system
• Performs other duties as assigned
• Complies with all policies and standards

Qualifications

Education

• Bachelor's Degree (BS or BA) required
• Master's Degree (MBA, MS, MA) preferred
• Degree in information technology, computer software, programming, etc. preferred

Experience

• 7-9 years overall; required
• 1-3 years leadership experience required
• 4-6 years 5 years with a master’s degree; required
• 1-3 years leadership required
• Experience in QMS, QA, QC, or Quality Auditing preferably in an environment such as blood banking, pharmaceutical, medical devices, or a hospital required
• Program Leadership experience preferred
• Experienced in good practices for computerized systems in regulated “GxP” environments preferred

Knowledge, Skills and Abilities

• Demonstrated ability to read, interpret, and apply regulations and standards applicable to the operations of BCW including FDA, CLIA (Clinical Laboratory Improvement Act), AABB (American Association of Blood Banks), CAP (College of American Pathology), FACT (Federation for Accreditation of Cellular Therapy), NMDP (National Marrow Donor Program), AATB (American Association of Tissue Banks), AOPO (Association of Organ Procurement Organizations), and applicable state pharmacy regulations
• Expert knowledge of using professional concepts and company policies and procedures to solve a variety of problems
• Expert knowledge of GxP requirements preferred
• Expert knowledge of standardized rules, procedures, and operations across multiple service lines, including those of computerized systems in GxP environments
• Involves the use of broad theoretical knowledge or advanced knowledge of highly specialized fields and their interrelationships
• Determines a course of action based on guidelines and may lead the development/implementation of new policies/ideas in area of responsibility
• Interpersonal and mentoring skills necessary to interact effectively with and ensure development of employees.
• Leads the development of new policies/ideas in own discipline
• Determines a course of action based on guidelines, but possesses the knowledge and experience to make decisions and set goals based on limited precedent
• Proven experience as a Quality Leader/Manager
• Capable of managing multiple projects simultaneously
• Ability to adapt to changing organizational and operational needs; ability to lead others through change.
• Ability to work under pressure (in an extremely fast paced environment), meet deadlines and make effective decisions.
• Exercises independent judgment within defined procedures and practices and may receive limited instruction
• Must be able to effectively communicate ideas (verbally and in writing), be a self-starter and handle difficult reporting situations.
• Experienced people leader with 8 years business/leadership experience building, leading, and/or managing a team of Quality Assurance professionals
• Excellent communication and business acumen skills.
• Proficiency in Microsoft Office and other computer/software applications
• Knowledge of Electronic Document Systems preferred.

Licenses and Certifications

• Quality Certifications highly preferred (i.e., ASQ CQA, ASQ CMQ/OE) preferred

Tools and Technology

• Personal Computer (desktop, laptop, tablet) required
• General office equipment (computer, printer, fax, copy machine) required
• Microsoft Suite (Word, Excel, PowerPoint) required
• Software validation tools and technology required