Director, Quality (Clinical Laboratory)

Regulatory Jobs; Cleveland (OH); Vor Ort; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

Regulatory Jobs is seeking a Director of Quality to lead the Quality Assurance function and the CA CLS Limited License Training Program. You will coordinate QA activities, drive quality systems, and ensure compliance with federal and state laboratory regulations.

The role reports to senior leadership and collaborates across the business unit. The ideal candidate has 10+ years in clinical lab settings, strong leadership, and regulatory expertise.

Qualifikationen

• 10+ years in a Clinical Laboratory setting.
• 5+ years of demonstrated leadership and management responsibilities.
• 3+ years in a Regulatory Environment or knowledge of state/federal requirements.

Aufgaben

• Coordinate and direct all functions of Quality Assurance.
• Oversee Quality Improvement System, state licensure, and training program.
• Lead audits related to ISO, CAP, and regulatory agencies.
• Ensure training competency and document control across the unit.
• Develop scorecard metrics and management review documentation.
• Respond to customer feedback and drive continuous improvement.
• Advise leadership on quality status and non-conformities.
• Manage quality staff and lead a team of direct and indirect reports.

Kenntnisse

Quality Improvement

Communication skills

Independent work

Cross-functional collaboration

Ausbildung

Bachelor’s Degree

Master’s Degree or PhD or MBA

Jobbeschreibung

The Director, Quality is directly responsible for coordinating and directing all functions of Quality Assurance and theCA CLS Limited License Training Program. This position assumes responsibility for ensuring that all technical and business requirements for laboratory testing are in place and maintained through theQualityManagementSystem.

The Director, Quality sitsasamemberoftheBusinessUnit'sLeadershipTeamand is responsible for participating in all associated communications, planning and coordination activities and works closely with Managing Director-Operations/Business/Staffing.

• Ensurecompliancewithfederalandstatelawsandregulationsconcerninglaboratorytesting procedures and results.
• OverseeandmanageoperationsforQualityAssurance,theQualityImprovementSystem, State Licensure, and the CA CLS Limited License Training Program.
• ManagetheQualityImprovementSystem,whichincludes Root Cause Analysis,CorrectiveandPreventativeAction (CAPA) and Annual Quality Improvement Plans.
• DirectinternalandexternalauditsrelatedtoISO,CAP,StateLaboratoryAgenciesand Clinical Trials.
• Ensure quality of new test validations, including Laboratory Developed Tests
• Responsible for preparedness, the audit process, and follow-up activities.
• Ensure an effective program of Document Control is in place.
• Coordinate and approve development of scorecard metrics and goals for Business Unit.
• Prepare and maintain Management Review document
• Coordinate corporate quality and Customer directives with local procedures.
• AssureaccurateandtimelyresponsetoCustomerFeedbackanddemonstratecontinuous improvement to Customer Satisfaction Survey Scores.
• EnsureTrainingandcompetencyrequirementsaredefinedandachievedattheBusiness Unit.
• Responsible for Business Unit's compliance with Clinical Trials Service Level Agreement.
• Identify and relate the quality control, quality management requirements of Quest Diagnostics Inc. and the State, Federal and other agencies to department directors, managers,andsupervisorstoensurethattheserequirementsareimplementedandauditd
• for compliance.
• Advise the appropriate supervisor, managers, or technical director, if and when requirements are not met. Inform the Medical Director of such deviations.
• Advise the Medical Director regarding the quality status of the laboratory on a regularly scheduled basis.
• Manage off-site and in-house inspections, as required.
• Assemble and maintain procedures of Quality Assurance Department.
• Responsible for the selection, retention, training, evaluation and counseling of the Quality Assurance staff.
• Perform other related duties are requested by the Medical Director, and/or Managing Director.

Required Work Experience:

• 10+ years in a Clinical Laboratory setting.
• 5+ years of demonstrated leadership and management responsibilities.
• 3+ years of experience in a Regulatory Environment or demonstrated knowledge in state and federal regulatory requirements.

Knowledge:

• Demonstrated knowledge in state and federal regulatory requirements.

Skills:

• Demonstrated skills and training in Quality Improvement.
• Excellent communication skills, verbal and written.
• Ability to work without direct supervision.
• Demonstrated ability to collaborate effectively across teams and functions.

People Leader Responsibility:

• Responsible for the selection, retention, training, evaluation and counseling of the Quality Assurance staff.
• 4 Direct reports and 3 Indirect Reports

Education

• Bachelor’s Degree (Required)
• Master’s Degree or PhD in Life Sciences or MBA highly desirable. (Preferred)