Senior Director, Quality Assurance - Southeast Region

Job Description

The Senior Director of Quality Assurance is responsible for establishing, maintaining, and overseeing the quality management systems for the Southeast Region. The Senior Director will partner with other senior leaders on national continuous improvement initiatives and ensure that all operations within the Region/Sub Region comply with federal, state, and local regulatory requirements (e.g. CLIA, CAP, ISO) and internal quality standards.

The successful candidate will drive continuous quality improvement, oversee comprehensive audit programs, manage critical quality systems software, and lead strategic quality initiatives for the Region/Sub Region, while collaborating and aligning with other senior quality team leaders from the centralized and regional/sub teams.

This position will be based in Tampa, FL (hybrid).

Responsibilities:

Strategic Quality Management Excellence

• Direct site and regional budgeting processes, focusing on resource allocation for continuous improvement projects, certifications, and personnel training.

• Operations QA Oversight: Enable QA leadership team to manage, analyze, and utilize QA data for real-time operational adjustments as part of DSM.

• Internal Quality Events (IQE) Tracking: Enable the QA leadership team to facilitate, review, and trend Laboratory Director (LD) approvals for IQEs and direct Revised Reports excellence.

• Metric Tracking & Reporting: Provide updates to National, Regional or Sub Regional leadership on Tier 1 operational quality metrics, specifically focusing on College of American Pathologists Proficiency Testing (CAP-PT) Defects Per Million Opportunities (DPMO) and Revised Reports rates.

• Partner with national and regional leadership teams to ensure all strategic new technology roll outs meet requirements and successful outcomes.

• Identifies, initiates, establishes, and develops long-term strategic relationships and alliances with key organizational stakeholders

• Partner directly with the Regional Vice President of Sales and Commercial Account Executives to build "Quality-First" materials for large-scale prospects, serving as the primary quality subject matter expert (SME) during sales presentations to prospective hospital systems, and managed care organizations.

• Drive the quality mindset, cross-functionally, throughout the Region/Sub Region by serving as a member of the Regional/Sub Regional Leadership Team providing solutions to problems and issues faced which are complex, undefined, and can impact multiple businesses or functions. 

• Participate in and liaise with the external professional, regulatory and educational community, representing Quest and influencing development of applicable regulations.

Compliance and Audit Excellence Management

• External Audits: Enable successful audit outcomes through the QA leadership team across the various assigned teams, including hands-on GEMBA walks and external audits including CAP, CLIA, DOH and contracted client assessments.

• Internal Assessments: Provide oversight of the annual Departmental Internal Assessments process to verify policy and procedural compliance and readiness for external regulatory inspections.

• Licensing & Financial Administration: Mobilize a regional/ sub regional program for all QA-related payments, invoices, licensing fees, permits, and proficiency testing subscriptions.

• Personnel & Director Liaison: With QA leadership team, facilitate administrative and regulatory updates regarding Laboratory Director changes, ensuring timely notifications to regulatory agencies.

• Proficiency Testing Compliance: Oversee leadership team to confirm all lab personnel complete required Proficiency Testing (PT) referral training as assigned, maintaining zero-tolerance compliance for PT referral violations.

• Partner with commercial and contracts leadership to strategize, standardize and evaluate client agreements, including what information can and should be shared with external entities for Quality Assurance excellence.  Actively participate in Request for Proposal (RFP) cycles to showcase Quest's industry-leading Quality Management System (QMS).

Quality System Excellence 

• Non-Conformance Management: Oversee the (State, Evaluate, Investigate, Cause, Action, Review) process for investigating and resolving quality deviations, sharing learnings with national QA leadership.

• System Administration: Direct the administration of key quality software platforms, specifically Smartsolve (for document control and administration) and MediaLab, for training, competency and non-conformances, through team members.

• SOP Management: Oversee the QA team to manage the rollout, tracking, and compliance of Standard Operating Procedures (SOPs) and specialized Quality SOPs.

• Validation Review Excellence: Mobilize excellence of validation reviews, ensuring rigorous standards are met for the implementation of new assays, equipment, and software systems prior to clinical use.

• Proficiency testing program management oversight through QA management team. 

Continuous Improvement Management

• Staff Development & Training: Direct QA leadership team to design and deliver formal and informal training sessions for laboratory staff on accreditation-required processes and quality systems (such as document control, training and competency, environmental monitoring, validation protocols, and non-conformance management) when needed.

• Meeting Leadership: Lead QA department meetings to align team members on quality objectives, share key performance indicators, and coordinate action items.

• Quality Improvement (QI) Review: Partner with peer Quality senior leaders, nationally, to ensure the establishment of a program which evaluates the effectiveness of implemented Quality initiatives and corrective/preventive actions to ensure sustainable operational improvement.

• Partner across the enterprise to drive improvements based on TNP general trends, leading to customer, patient and employee satisfaction and while differentiating Quest.

• With a bias toward action, review data trends to optimize quality for the region/business unit, sharing learnings across the national quality team.

• Investigation Oversight: Oversee the QA workflow, ensuring, methodology support, and final oversight for Regional Quality Investigations (RQI) and large-scale quality event investigations.

People Leadership

• Lead, coach, and develop QA leadership team to achieve regional/sub and national organizational goals and business objectives, providing clear expectations and addressing performance when appropriate.

• Ensure best practices are utilized for QA leadership team to manage talent by engaging with talent acquisition to fill roles, developing succession plans, and consistently evaluating workforce plans and organizational capabilities.  Serve as a bridge for talent to move across the enterprise.

• Promote employee retention through engagement and career development initiatives.

• Regularly strategize and formulate actions, deploying them to the QA leadership team, to build and maintain an inclusive, respectful, and collaborative work environment.

• Cultivate team environment to recognize and celebrate individual and team achievements. 

Qualifications:

• A bachelor’s degree in Medical Technology, Clinical Laboratory Science, Biology, Chemistry, or a related scientific field is required.  An advanced degree is preferred.

• State clinical laboratory licensure (where applicable) is required.  ASCP (MT/MLS/CLS) licensure is preferred.

• Certified Quality Auditor (CQA) or Certified Manager of Quality/Organizational Excellence (CMQ/OE) certification through ASQ is strongly preferred.

• Certification in Lean/Six Sigma and/or Laboratory Quality Management Systems is also preferred.

• A minimum of 15 years of progressive experience working within a CAP/CLIA - regulated clinical laboratory environment, with at least 10 years of QA leadership experience.

• Experience in both a clinical and anatomic pathology diagnostics laboratory setting is strongly preferred.

• 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.

• Up to 25% travel will be required.

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