Job Title: Director of Quality

Location: Louisville, KY

Type: On-site ; Full-time Employment

About the job

The Director of Quality will provide leadership and direction to the quality operations team overseeing clinical laboratory testing, the quality system of the laboratory and study execution. Responsible for activities related to Quality Department financial management, productivity, strategic planning, continuous improvement, staff development and management, procedures, and developing and implementing new services. Completes special assignments as assigned by the laboratory management team. Responsible ensuring that the laboratory meets quality and productivity standards and complies with all regulatory and safety standards as defined by CAP, JCAHO, CLIA, NYDOH, CA and OSHA.

Essential Responsibilities/Duties:

Quality Oversight and Leadership:

• Provide technical and quality oversight of laboratory operations and personnel.

• Assist in planning, implementing, and monitoring the Quality Management System (QMS).

• Collaborate with the Laboratory Director on standardizing laboratory quality systems.

• Ensure laboratory test performance specifications are established, verified, and maintained.

• Monitor quality metrics and take remedial actions to ensure compliance and proper test system functioning.

• Direct and coordinate quality activities to ensure timely service provision within quality and cost objectives.

• Prioritize projects based on business needs and collaborate with laboratory managers on quality, performance, and scaling issues.

• Act urgently on operational issues to meet regulatory and compliance needs.

• Provide troubleshooting expertise for out-of-control systems or tests.

Quality Assurance and Compliance:

• Collaborate on Quality Assurance updates and review CLIA regulations.

• Serve as an expert resource on licensure and compliance issues.

• Ensure all laboratory activities comply with local, state, federal, and governmental regulations.

• Ensure documentation, correction, and follow-up of quality and safety events.

• Participate in internal/external audits (CAP).

• Identify improvement opportunities and utilize continuous improvement methods.

• Verify and assess documentation for completion and accuracy, including QC, proficiency testing, study methods, and equipment maintenance records.

• Lead quality investigations to determine root causes of non-conformances, initiating corrective and preventative actions.

• Assist and provide guidance on new method validations and implementation strategies.

Quality Program Development:

• Lead the development of an ongoing continuous quality management system.

• Review monthly metrics and assist in corrective action/procedural changes.

• Participate in quality/safety committee meetings and prepare annual quality assessment plans.

• Work with Technical Supervisors and IT to develop quality data across sites.

Process Improvement and Implementation:

• Evaluate and assist with lean projects to improve laboratory processes.

• Develop quality training modules and ensure adequate personnel training.

• Understand the impact of sample preparation functions on workflow and result quality.

Leadership in Test Development and Validation:

• Provide analytical and clinical validation services.

• Design and review validation plans for complex tests.

• Ensure all test development meets regulatory needs and assist with troubleshooting and validation.

• Write or update SOPs and assist with training.

• Assist with planning for future test volumes and laboratory design.

Setup of New Satellite Labs:

• Validate all instrumentation/platforms and sample matrices/collection devices to meet regulatory requirements.

• Provide SOPs for validation exercises and summary reports for inspection.

• Offer mock inspection services for accreditation and certification status.

• Monitor and implement workflow automation and scaling.

Qualifications:

Education:

• Master’s degree or PhD in Biological Sciences.

• At least 8 years of related experience and/or training in a commercial, clinical, environmental, analytical, or genetic laboratory environment.

Competencies/Skills:

• Effective communication with various level stakeholders.

• High proficiency in Microsoft Word, PowerPoint, and Excel.

• Self-motivated with the ability to take ownership of projects.

• Ability to travel up to 50%.

Experience:

• In-depth knowledge of complex laboratory techniques, safety, and quality assurance.

• Experience in statistical data analysis and management.

• Proficiency in creating and maintaining policies, procedures, spreadsheets, and data management.

Job Type: Full-time

Pay: $120,000.00 - $150,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Experience:

• ISO 9001: 1 year (Preferred)

Ability to Commute:

• Louisville, KY 40202 (Preferred)

Ability to Relocate:

• Louisville, KY 40202: Relocate before starting work (Required)

Work Location: In person