Senior Director, Quality Assurance - Southeast Region

Quest Diagnostics•Tampa, FL

11d•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 coordination with centralized and regional quality leaders. The position is based in Tampa, Florida, with a hybrid workplace arrangement and up to 25% travel required. The Senior Director oversees strategic quality management, regulatory compliance, audits, quality systems, continuous improvement, and people leadership. The role leads and develops the QA leadership team, advances quality initiatives across the region, and represents the organization in regulatory, professional, client, and sales-related activities.

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.
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

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.
Familiarity with laboratory environmental monitoring systems.

Responsibilities

Direct site and regional budgeting processes, with a focus on resources for continuous improvement projects, certifications, and personnel training.
Enable the QA leadership team to manage, analyze, and use QA data for real-time operational adjustments as part of DSM.
Enable the QA leadership team to facilitate, review, and trend Laboratory Director approvals for internal quality events and promote revised-report excellence.
Report Tier 1 operational quality metrics to national, regional, or subregional leadership, including CAP proficiency-testing DPMO and revised-report rates.
Partner with national and regional leaders to ensure strategic technology rollouts meet requirements and achieve successful outcomes.
Develop long-term strategic relationships with organizational stakeholders.
Partner with regional sales and commercial account leaders to develop quality-focused materials for large prospects 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 as a member of the Regional/Sub Regional Leadership Team, providing solutions to complex and broadly impactful issues.
Participate in and liaise with external professional, regulatory, and educational communities, representing Quest and influencing applicable regulations.
Enable the QA leadership team to support successful external audits, including CAP, CLIA, DOH, and contracted client assessments, with hands-on GEMBA walks as applicable.
Oversee annual departmental internal assessments to verify compliance with policies and procedures and readiness for regulatory inspections.
Coordinate regional or subregional QA-related payments, invoices, licensing fees, permits, and proficiency-testing subscriptions.
Facilitate regulatory and administrative updates concerning Laboratory Director changes and ensure timely notifications to regulatory agencies.
Oversee compliance with required proficiency-testing referral training and maintain zero-tolerance compliance for PT referral violations.
Partner with commercial and contracts leadership to strategize, standardize, and evaluate client agreements, including decisions about information shared with external entities.
Participate in RFP cycles to present the organization’s Quality Management System.
Oversee the State, Evaluate, Investigate, Cause, Action, Review process for investigating and resolving quality deviations and share learnings with national QA leadership.
Direct administration of Smartsolve and MediaLab quality software platforms through team members.
Oversee QA management of the rollout, tracking, and compliance of Standard Operating Procedures 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 training on accreditation-required processes and quality systems, including document control, training and competency, environmental monitoring, validation protocols, and non-conformance management.
Lead QA department meetings to align team members on quality objectives, performance indicators, and action items.
Partner with peer national quality leaders to establish a program evaluating the effectiveness of quality initiatives and corrective/preventive actions for sustainable improvement.
Partner across the enterprise to drive improvements based on TNP general trends, supporting customer, patient, and employee satisfaction.
Review data trends to optimize quality for the region or business unit and share learnings across the national quality team.
Oversee QA workflows, 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 regional, subregional, and national goals and business objectives.
Set clear expectations and address performance when appropriate.
Ensure the QA leadership team uses talent-management best practices, including recruitment, succession planning, and workforce and organizational capability evaluation.
Support talent mobility across the enterprise and promote retention through engagement and career development initiatives.
Deploy actions that build and maintain an inclusive, respectful, and collaborative work environment, and recognize individual and team achievements.