Director, Quality Management Systems - Clinical Labs

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About Duke University Health System Clinical Laboratories

Pursue your passion for caring and innovation as a team member in the state-of-the-art Duke Health laboratories. Duke Health laboratories are College of American Pathologists accredited and Clinical Laboratory Improvement Amendments certified. The multidisciplinary team is committed to serving the rare and complex testing needs of Duke Health's diverse patient population by providing timely and accurate results, educating the next generation of laboratorians, scientists and physicians, and researching and developing the cutting-edge diagnostics of tomorrow.

General Description
The Director of Quality Management Systems oversees the strategic direction and execution of key programs within Duke Health Clinical Laboratories, including Quality Management, Environmental and Employee Safety, Licensure and Accreditation, and Performance Improvement. As a senior management team member, this role plays a critical part in the leadership structure of the clinical laboratories and collaborates closely with Duke Health corporate service leaders in related domains. The Director is responsible for guiding and maintaining quality systems, ensuring regulatory compliance, and educating laboratory staff on relevant policies and procedures.

Lead Program Development: Design and implement programs related to Quality Management, Environmental and Employee Safety, Licensure and Accreditation, and Performance Improvement across Duke Health Clinical Laboratories.

Manage Quality Team: Supervise the quality management team and ensure effective collaboration with laboratory staff to carry out these programs.

Establish and Monitor Standards: Develop policies and procedures, track performance metrics, assess risks, and conduct mock inspections. Report findings to senior leadership.

Regulatory Oversight: Coordinate inspections and maintain communication with regulatory agencies to ensure compliance.

Staff Education and Communication: Provide staff with the knowledge and training needed to support quality, safety, accreditation, and performance improvement efforts.

Maintain Professional Knowledge: Stay current by engaging with internal and external resources such as Accreditation & Patient Safety, Risk Management, OESO, and professional organizations like ASQ, CDC, CAP, JCAHO, ASHI, AABB, and FACT.

Required Qualifications
Education:
Master’s degree in Healthcare Administration, Business, or Clinical Laboratory Science required.
Experience:
Minimum of five years of progressive leadership experience in clinical laboratory quality management or a related healthcare setting.
Licensure and Certification:
Additional certifications such as Lean Six Sigma, Certified Professional in Healthcare Quality (CPHQ), American Society for Quality (ASQ), or Project Management Professional (PMP) are highly desirable.
Knowledge, Skills, and Abilities:
Proven leadership and team management skills in a complex healthcare environment.
Strong written and verbal communication abilities, including scientific and analytical writing.
Expertise in data analysis, quality metrics, and performance improvement methodologies.
Proficiency in Lean, Six Sigma, and other process improvement frameworks.
Deep understanding of regulatory standards and accreditation requirements (e.g., CAP, CLIA, JCAHO).
Ability to lead mock inspections, risk assessments, and continuous quality improvement initiatives.
Skilled in change management, strategic planning, and cross-functional collaboration.
Familiarity with clinical laboratory operations, patient safety, and compliance frameworks.
Comfortable using quality management software, data visualization tools, and reporting platforms.

Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy related conditions), sexual orientation or military status.

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Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.