Manager of Quality Systems (Piedmont)

Position Overview The Manager of Quality Systems is responsible for development, implementation, management, and ongoing coordination of quality management systems to ensure ongoing compliance with regulations, standards, and industry best practices applicable to The Blood Connection. The position assists the VP of Quality Systems with maintenance and improvement of organizational quality processes. Essential Functions QUALITY Collaboratively supports organizational quality systems, processes, and objectives Monitors the release of new or revised regulations and standards, evaluating the impact on current processes and practices, and recommends changes if necessary to ensure sustained compliance Serves as a point person for external assessments and effectively communicates with assessors and TBC executive management, directors, and managers during an external assessment Participates in the organizational change management process, providing guidance and support to ensure changes are executed in a manner that maintains regulatory compliance Reviews investigations of reported occurrences and participates in the investigation, root cause analysis, and development of corrective action plans Participates in investigations and reviews reports of suspected post transfusion adverse reaction, providing guidance and execution of required product recalls and withdrawals Communicates with regulatory or accrediting agencies as required (e.g., reportable events, external assessment findings, license submissions) Directs the execution of internal assessments for the organization’s systems and processes promoting compliance and readiness for external assessments Develops and implements process control measures (e.g., process flowcharts, benchmarking, key performance indicators) Maintains training materials supporting organizational understanding of current good manufacturing practices (cGMPs) Monitors processes performed by the Quality team and makes recommendations to the VP of Quality Systems to enhance performance and reduce operational risk Assists with regulatory licensing submissions for processes or blood products manufactured with the intention of interstate commerce Some travel required   Other Duties Other duties as assigned. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.   Minimum Qualifications Bachelor’s Degree from a four-year college or university ASQ certification preferred (e.g., CQA, CQM/OE) Minimum five years of experience managing quality and/or safety teams and processes Five years of progressive experience in a blood center or related field preferred Experience working with regulatory agencies (e.g., OSHA, FDA) Experience with data analysis and risk assessments Experience delivering training to a range of audiences Proficient with Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook Ability to work productively in highly collaborative settings while also able to function independently Must demonstrate a high level of professionalism Ability to prioritize, multi-task, and meet deadlines Excellent communication and presentation skills, both written and verbal Excellent organization, critical thinking, reasoning, and problem-solving skills Ability to communicate effectively and courteously Must demonstrate an acceptable level of competence with standard operating protocols used throughout TBC   Physical Demands The physical demands described here are representative of those that must be met to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Lifting up to 25 pounds Sitting, standing, or walking for an extended period of time Occasional bending and twisting