Senior Director, Quality Assurance - Southeast Region

Quest Diagnostics•Tampa, FL

12d•Hybrid

About The Position

The Senior Director of Quality Assurance establishes, maintains, and oversees quality management systems for the Southeast Region. The role partners with senior leaders on national continuous-improvement initiatives and ensures regional operations comply with federal, state, and local regulations, including CLIA, CAP, and ISO requirements, as well as internal quality standards. The position drives continuous quality improvement, oversees audit programs and quality systems software, and leads strategic quality initiatives in collaboration with centralized and regional quality leaders. It is based in Tampa, Florida, with a hybrid work arrangement and requires up to 25% travel.

Requirements

Bachelor’s degree in Medical Technology, Clinical Laboratory Science, Biology, Chemistry, or a related scientific field.
State clinical laboratory licensure where applicable.
At least 15 years of progressive experience in a CAP/CLIA-regulated clinical laboratory environment.
At least 10 years of QA leadership experience.
Proficiency with laboratory quality management software.
Familiarity with laboratory environmental monitoring systems.
Strong working knowledge of statistical analysis, root-cause analysis methodologies, and CAP/CLIA/COLA/ISO 15189 and DOH regulations.
Ability to travel up to 25%.

Nice To Haves

An advanced degree.
ASCP (MT/MLS/CLS) licensure.
Certified Quality Auditor (CQA) or Certified Manager of Quality/Organizational Excellence (CMQ/OE) certification through ASQ.
Certification in Lean/Six Sigma and/or Laboratory Quality Management Systems.
Experience in both clinical and anatomic pathology diagnostics laboratory settings.

Responsibilities

Direct site and regional budgeting, allocating resources for continuous-improvement projects, certifications, and personnel training.
Enable the QA leadership team to use QA data for real-time operational adjustments as part of DSM.
Oversee tracking and review of Internal Quality Events, Laboratory Director approvals, and Revised Reports performance.
Report Tier 1 operational quality metrics to national, regional, or subregional leadership, with emphasis on CAP-PT DPMO and Revised Reports rates.
Partner with national and regional leaders to ensure successful, compliant rollouts of new technologies.
Develop long-term strategic relationships and alliances with organizational stakeholders.
Partner with regional sales leadership and commercial account executives to create quality-focused materials and serve as the quality subject matter expert in presentations to prospective hospital systems and managed care organizations.
Promote a quality mindset across the region and contribute to the Regional/Sub Regional Leadership Team by addressing complex, cross-functional issues.
Represent Quest in external professional, regulatory, and educational communities and contribute to the development of applicable regulations.
Enable successful external audits, including CAP, CLIA, DOH, and client assessments, and conduct hands-on GEMBA walks.
Oversee annual departmental internal assessments for policy and procedural compliance and external inspection readiness.
Coordinate regional QA payments, invoices, licensing fees, permits, and proficiency-testing subscriptions.
Coordinate regulatory and administrative updates concerning Laboratory Director changes and ensure timely agency notifications.
Oversee compliance with required proficiency-testing referral training and maintain zero-tolerance compliance for PT referral violations.
Partner with commercial and contracts leadership on client agreements and information-sharing standards; participate in RFP cycles to present Quest’s Quality Management System.
Oversee the State, Evaluate, Investigate, Cause, Action, Review process for quality deviations and share lessons with national QA leadership.
Direct administration of Smartsolve and MediaLab quality software through team members.
Oversee rollout, tracking, and compliance of standard and specialized Quality SOPs.
Ensure rigorous validation reviews for new assays, equipment, and software before clinical use.
Oversee proficiency-testing program management through the QA management team.
Direct the QA leadership team in developing and delivering staff training on accreditation-required processes and quality systems.
Lead QA department meetings to align team members on objectives, performance indicators, and action items.
Partner with national quality leaders to evaluate the effectiveness and sustainability of quality initiatives and corrective/preventive actions.
Partner across the enterprise to drive improvements based on TNP trends and support customer, patient, and employee satisfaction.
Review data trends to improve quality for the region/business unit and share learnings across the national quality team.
Oversee QA workflows and provide methodology support and final oversight for Regional Quality Investigations and large-scale quality-event investigations.
Lead, coach, and develop the QA leadership team to meet organizational goals, set clear expectations, and address performance as appropriate.
Support talent acquisition, succession planning, workforce planning, organizational capability assessment, and movement of talent across the enterprise.
Promote employee retention through engagement and career development initiatives.
Develop and deploy actions that foster an inclusive, respectful, and collaborative work environment.
Cultivate a team environment that recognizes and celebrates individual and team achievements.