The ideal candidate for this position will have a background as a Medical Technologist (or other Allied Health field) and be ASCP certified.
This position is responsible for directing all strategic planning activities and initiatives for regulatory management of clinical operations for PLM departments. This position is also responsible for directing the planning, execution, analysis and evaluation of complex projects related to regulatory accreditation agencies for clinical operations, information technology, education, and other related areas within the Division of Pathology Lab Medicine. This position will be responsible for the FDA, CAP, and CLIA/CMS, AABB accreditation and regulatory programs for the Division, including maintaining current licensure and submission of required annual FDA report for Division of Pathology and Laboratory including the HAL's.
Clinical Operations Regulatory Management
Responsible for compliance with applicable policies and procedures
Recruits, coaches and develops regulatory talent
Provides general direction to all levels of employees across the division to ensure overall compliance with regulatory practices
Demonstrates effective change management skills
Builds strategic partnership to further develop department and organization objectives
Interacts with executive level management, laboratory leadership, clinical staff and outside regulatory agencies
Serve as consultant to hospital regulatory leaders as required
Directs the oversight of Multiple Quality Systems: Document Control, Procedure Development, Change Control, Deviation Management, Systems Validation, and Corrective and Preventive Actions, Donor Notifications, and Recalls
Oversees all practices related to monitoring and preventative maintenance of equipment and instrument quality control.
Responsible for the FDA, CAP, and CLIA/CMS, AABB accreditation and regulatory programs for the Division, including maintaining current licensure and submission of required annual FDA report.
Manages, Monitors and Maintains Regulatory Compliance
Oversees and effectively communicates current information regarding regulatory requirements while demonstrating job knowledge and proficiency to monitor evaluate and improve the quality efficiency and appropriateness of section testing, processes for all main campus Labs as well as HAL's.
Develops, implements, and maintains the Quality Management Plan, Quality Assurance
Manual, and Performance Improvement Plan for the sections including HAL's.
Oversee standards for reviewing and monitoring quality control activities for the sections across the
Directs institutional, and divisional requirement initiatives to assure sections remain compliant.
Facilitates the preparation for regulatory agency inspections and works with Depts/sections and HAL personnel on the corrective actions to meet requirements.
Directs and oversees all quality audits and documentation of errors and accidents
Oversees Mock Inspections for all clinical laboratories including the HAL's.
Facilitates Quality Improvement
Direct all activities of Quality Audits for the Division. Reviews deviations, problems and data to identify opportunities for improvement.
Plans and implements quality improvement projects based on reviews.
Reports and/or reviews all change control submissions, CAP proficiencies, deviations, FDA reportable errors, complaints, and adverse reactions.
Oversee identification and development of appropriate indicators, as well as collecting data for quality improvement indicators and projects for all laboratory sections including HAL's.
A. Interacts with all levels of institutional personnel including Division Heads, Division Chairs, Laboratory Leadership team members, Vice Presidents, etc.
B. Participates in the recruitment and selection of divisional administrative leaders, including Department Administrators.
C. Participates on numerous and varied cross-divisional projects as a division office representative and leader.
D. Conducts routine and special audits as needed concerning charge capture, account reconciliation, financial practices, etc. (Example: informing Revenue Integrity of misplaced and missing revenue and provide counsel)
Education and Training
Directs educational component to keep staff current on various issues impacting both regulatory and quality management systems.
Provides direction to all clinical laboratory staff across PLM on how to access resources to facilitate quality and regulatory guidelines in compliance with governing bodies.
Master's degree in Business Administration, Hospital/Healthcare Administration or related field. Eight years of business management experience to include four years of management experience in a health care environment. May substitute required education degree with additional years of equivalent experience on a one to one basis. It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
Requisition ID: 127473
Employment Status: Full-Time
Employee Status: Regular
FLSA: exempt and not eligible for overtime pay
Work Week: Days
Fund Type: Hard
Pivotal Position: No
Minimum Salary: US Dollar (USD) 111,600
Midpoint Salary: US Dollar (USD) 139,500
Maximum Salary : US Dollar (USD) 167,400
University Of Texas M.D. Anderson