Manager – Quality and Compliance

In addition to the responsibilities listed below, this position is also responsible for leading the implementation of laboratory quality assurance (QA) plans to support continuous improvement in assigned area; ensuring alignment with regional standards for laboratory quality of service; establishing short and long-term quality assurance goals and objectives consistent with strategic and business plans, and guiding team members to execute; resolving escalations regarding complex laboratory problems; training and developing team members to complete inspections of laboratory locations within the region to ensure compliance with regulatory requirements, QA systems, testing procedures, personnel, physical plant, and equipment; providing high level guidance regarding team member collaborations with lab personnel, including reviewing recommendations for laboratory quality control systems; managing the monitoring, maintenance, and user training for quality systems; guiding the development of quality administrative policies; reviewing audit surveys to ensure compliance with regulatory requirements; facilitating cross-department work to coordinate selection, ordering, submissions, and responses for proficiency testing surveys; and managing the implementation of total quality management tools and techniques to improve lab operations.

• Provides developmental opportunities for others; builds collaborative, cross-functional relationships. Solicits and acts on performance feedback; works closely with employees to set goals and provide open feedback and coaching to drive performance improvement. Pursues professional growth; develops and provides training and development to talent for growth opportunities; supports execution of performance management guidelines and expectations. Leads, adapts, implements, and stays up to date with organizational change, challenges, feedback, best practices, processes, and industry trends. Fosters open dialogue amongst team members, engages, motivates, and promotes collaboration within and across teams. Delegates tasks and decisions as appropriate; provides appropriate support, guidance, and scope; encourages development and consideration of options in decision making.
• Manages designated work unit or team by translating business plans into tactical action items; oversees the completion of work assignments and identifies opportunities for improvement; ensures all policies and procedures are followed. Aligns team efforts; builds accountability for and measuring progress in achieving results; determines and ensures processes and methodologies are implemented; resolves escalated issues as appropriate; sets standards and measures progress. Fosters the development of work plans to meet business priorities and deadlines; obtains and distributes resources. Removes obstacles that impact performance; identifies and addresses improvement opportunities; guides performance and develops contingency plans accordingly; influences teams to execute in alignment with operational objectives.
• Maintains testing and training standards by\: ensuring alignment between the departments strategic initiatives and the development and implementation of technical and/or non-technical training materials while allocating training resources; evaluating relevant personnel competency on an ongoing basis; and anticipating future training needs, planning regular, in-service, and competency training programs, and completing own training.
• Maintains compliance and accreditation by\: influencing and implementing policies and work instructions in alignment with applicable regulations, license requirements, accreditation standards, and inspection checklists pertaining to laboratories and facilities where testing is performed; routinely assessing adherence to all requirements related to the recruitment, processing, testing, storage, and distribution of materials and samples; identifying and implementing appropriate corrective and preventive actions for addressing technical and/or non-technical deficiencies in regulatory/accreditation inspection processes; supervising the renewal process for personnel licensure; and reviewing teams updates to technical and/or non-technical documentation.
• Serves as a link between medical laboratory services and other services by\: planning for the alignment of current practices with regulatory/accreditation changes and issues, inspection citations, current events, and trends relevant to services, quality, and training; leading cross-functional teams to proactively evaluate and improve technical and/or non-technical quality management systems; networking and collaborating across internal teams locally to coordinate and align lab operations, quality, and utilization; communicating with external vendors, local/state public health and safety organizations, and other health care providers; and driving alignment with local and national standards and regulations, and utilization of technology and initiatives.
• Ensures medical laboratory operations and improves processes by\: managing efficient operations, quality, service, patient safety, member/customer satisfaction, and cost effectiveness through evaluation and standardization of technical and/or non-technical services and processes; implementing innovative work plan processes to improve systems across the continuum of care; participating in the evaluation and implementation of new testing methodologies, processes, and technology that have the potential to improve service, quality, and/or efficiency; ensuring the resolution of onsite facilities issues of varying complexity with internal and external vendors; collaborating with employees to cultivate teamwork and a progressive work environment; managing personnel during periods of varying work load; monitoring the use of inventory and maintenance systems, building the supplies inventory, and estimating usage and costs; and managing ongoing technical and/or non-technical project management, including local, regional, and national initiatives, and status reports.
• Manages service quality by\: reviewing applicable policies and procedures for audit and process improvement projects; recommending, establishing, and implementing corrective actions, preventive actions, and process improvements based on internal and external quality audits of technical and/or non-technical processes; developing plans for correcting deviations from expected quality control results; analyzing the effectiveness of strategies used to ensure that tests are performed properly and results are verified before being shared; proactively anticipating and resolving potential barriers that may prevent specimens from being collected and processed according to established time and quality standards; resolving proficiency testing concerns; and driving the application of strategies to resolve problems of varying complexity related to pre-analytical (collection, processing, etc.), analytical, or post-analytical testing, as applicable.

In addition to the responsibilities listed below, this position is also responsible for leading the implementation of laboratory quality assurance (QA) plans to support continuous improvement in assigned area; ensuring alignment with regional standards for laboratory quality of service; establishing short and long-term quality assurance goals and objectives consistent with strategic and business plans, and guiding team members to execute; resolving escalations regarding complex laboratory problems; training and developing team members to complete inspections of laboratory locations within the region to ensure compliance with regulatory requirements, QA systems, testing procedures, personnel, physical plant, and equipment; providing high level guidance regarding team member collaborations with lab personnel, including reviewing recommendations for laboratory quality control systems; managing the monitoring, maintenance, and user training for quality systems; guiding the development of quality administrative policies; reviewing audit surveys to ensure compliance with regulatory requirements; facilitating cross-department work to coordinate selection, ordering, submissions, and responses for proficiency testing surveys; and managing the implementation of total quality management tools and techniques to improve lab operations.

• Provides developmental opportunities for others; builds collaborative, cross-functional relationships. Solicits and acts on performance feedback; works closely with employees to set goals and provide open feedback and coaching to drive performance improvement. Pursues professional growth; develops and provides training and development to talent for growth opportunities; supports execution of performance management guidelines and expectations. Leads, adapts, implements, and stays up to date with organizational change, challenges, feedback, best practices, processes, and industry trends. Fosters open dialogue amongst team members, engages, motivates, and promotes collaboration within and across teams. Delegates tasks and decisions as appropriate; provides appropriate support, guidance, and scope; encourages development and consideration of options in decision making.
• Manages designated work unit or team by translating business plans into tactical action items; oversees the completion of work assignments and identifies opportunities for improvement; ensures all policies and procedures are followed. Aligns team efforts; builds accountability for and measuring progress in achieving results; determines and ensures processes and methodologies are implemented; resolves escalated issues as appropriate; sets standards and measures progress. Fosters the development of work plans to meet business priorities and deadlines; obtains and distributes resources. Removes obstacles that impact performance; identifies and addresses improvement opportunities; guides performance and develops contingency plans accordingly; influences teams to execute in alignment with operational objectives.
• Maintains testing and training standards by\: ensuring alignment between the departments strategic initiatives and the development and implementation of technical and/or non-technical training materials while allocating training resources; evaluating relevant personnel competency on an ongoing basis; and anticipating future training needs, planning regular, in-service, and competency training programs, and completing own training.
• Maintains compliance and accreditation by\: influencing and implementing policies and work instructions in alignment with applicable regulations, license requirements, accreditation standards, and inspection checklists pertaining to laboratories and facilities where testing is performed; routinely assessing adherence to all requirements related to the recruitment, processing, testing, storage, and distribution of materials and samples; identifying and implementing appropriate corrective and preventive actions for addressing technical and/or non-technical deficiencies in regulatory/accreditation inspection processes; supervising the renewal process for personnel licensure; and reviewing teams updates to technical and/or non-technical documentation.
• Serves as a link between medical laboratory services and other services by\: planning for the alignment of current practices with regulatory/accreditation changes and issues, inspection citations, current events, and trends relevant to services, quality, and training; leading cross-functional teams to proactively evaluate and improve technical and/or non-technical quality management systems; networking and collaborating across internal teams locally to coordinate and align lab operations, quality, and utilization; communicating with external vendors, local/state public health and safety organizations, and other health care providers; and driving alignment with local and national standards and regulations, and utilization of technology and initiatives.
• Ensures medical laboratory operations and improves processes by\: managing efficient operations, quality, service, patient safety, member/customer satisfaction, and cost effectiveness through evaluation and standardization of technical and/or non-technical services and processes; implementing innovative work plan processes to improve systems across the continuum of care; participating in the evaluation and implementation of new testing methodologies, processes, and technology that have the potential to improve service, quality, and/or efficiency; ensuring the resolution of onsite facilities issues of varying complexity with internal and external vendors; collaborating with employees to cultivate teamwork and a progressive work environment; managing personnel during periods of varying work load; monitoring the use of inventory and maintenance systems, building the supplies inventory, and estimating usage and costs; and managing ongoing technical and/or non-technical project management, including local, regional, and national initiatives, and status reports.
• Manages service quality by\: reviewing applicable policies and procedures for audit and process improvement projects; recommending, establishing, and implementing corrective actions, preventive actions, and process improvements based on internal and external quality audits of technical and/or non-technical processes; developing plans for correcting deviations from expected quality control results; analyzing the effectiveness of strategies used to ensure that tests are performed properly and results are verified before being shared; proactively anticipating and resolving potential barriers that may prevent specimens from being collected and processed according to established time and quality standards; resolving proficiency testing concerns; and driving the application of strategies to resolve problems of varying complexity related to pre-analytical (collection, processing, etc.), analytical, or post-analytical testing, as applicable.

• Minimum three (3) years of experience in quality control, quality assurance, and clinical laboratory regulatory compliance.
• Minimum three (3) years of experience in a leadership role with or without direct reports in a healthcare related field.
• Bachelors degree in medical lab science or equivalent, or health care related field AND minimum six (6) years of experience in medical technology, clinical laboratory sciences, or health care related field OR Minimum nine (9) years of experience in medical technology, clinical laboratory sciences, or health care related field.

• Minimum three (3) years of experience in quality control, quality assurance, and clinical laboratory regulatory compliance.
• Minimum three (3) years of experience in a leadership role with or without direct reports in a healthcare related field.
• Bachelors degree in medical lab science or equivalent, or health care related field AND minimum six (6) years of experience in medical technology, clinical laboratory sciences, or health care related field OR Minimum nine (9) years of experience in medical technology, clinical laboratory sciences, or health care related field.

• Two (2) years experience leading or managing in a complex union/management environment.
• Two (2) years experience working with a large physician group practice.

• Two (2) years experience leading or managing in a complex union/management environment.
• Two (2) years experience working with a large physician group practice.

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