Clinical Laboratory Compliance Director / Director of Operations / Toxicology

  • Full-time

Company Description

We are a permanent placement company attempting to fill a position for a Clinical Laboratory Compliance Director in the Plano, TX area.  Under the general guidance of the COO, you would provide strategic and operational leadership to the Laboratory departments, providing leadership of individual employees and work teams to achieve defined goals, objectives and outcomes in service, quality, finance, engagement and growth and providing for the efficient management of department resources to achieve goals and outcomes.

Job Description

The primary role of the Clinical Laboratory Compliance Director is to oversee laboratory operations ensuring accurate testing results are presented to our customers in a timely and cost effective manner.  Maintain adherence to standard operating procedures, efficient work flow processing, staff training and development.  The operational functions include but are not limited to staff supervision and scheduling, testing, cost containment, workflow analysis, instrument maintenance, quality control and quality assurance.  This position will typically have a direct supervisory relationship of Laboratory Scientists and will work with the Laboratory’s Supervisor as part of a team to accomplish assigned duties, with ultimate interest of customer satisfaction. It is of the utmost importance, the Director, along with the Supervisor, provide supervision to the staff, maintain efficient work flow processing, manage costs, conduct staff training and adhere to standard operating procedures.  

Duties & Responsibilities:

  • Act as liaison between upper management and laboratory staff.
  • Ensure the laboratory meets customer quality and turnaround expectation.
  • Responsible for operating within the department budget.  Assure continuous process improvement by acquiring, analyzing and displaying the appropriate metrics.
  • Oversee Laboratory Scientists providing assistance and determining proper techniques in accordance with established processes and SOP’s.
  • Coordinate adequate staff and production scheduling to complete daily workload.  Interact with management to define staffing needs.
  • Implement staff training, competency and development including disciplinary action and conflict resolution.  Provide motivation and continuing education to staff.
  • Interview prospective employees.
  • Access, understand and retrieve laboratory operations aspects of the LIMS.
  • Familiar with and have basic knowledge of applicable instrumentation. Interact with management to define equipment and instrumentation needs.
  • Verify assay Quality Control and confirm QC is properly evaluated, performed, documented and appropriate corrective action is taken.
  • Ensure the laboratory is compliant with and performs training of staff, including but not limited to chain of custody, handling of forensic records, and confidentiality.
  • Lead corrective action in response to evaluating deficiencies and/or issues identified during batch, inspection or proficiency testing failures.
  • Demonstrate knowledge and competency in writing, maintaining and compliance with applicable Standard Operating procedures.
  • Comply with safety rules and regulations to include determining proper handling procedures of samples, cleanliness and neatness at the workstation and within the testing facility and observance of appropriate personal protective equipment procedures.
  • Perform other related duties as assigned.

Strategic Leadership:  In collaboration with upper management, maintains situational awareness of internal and external influences on business success, hospital and service industry directions, positive or adverse trends, opportunities for business development and assists in formulating strategy for
operational and hospital success; leads and actively participates in crossfunctional/interdisciplinary teams to achieve overall hospital strategic outcomes; communicates and interprets strategic plans with operational teams, aligning operational goals and performance measures  to accomplish strategic imperatives.

 

Operational Leadership:  Responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulation. Sets operational goals and objectives for assigned service areas, inviting and incorporating work team recommendations into plans for achieving goals and objectives; develops salient operational measures and monitors, routinely communicating results with work teams, identifying achievements and opportunities for improvement.  Addresses adverse trends and outcomes through development and implementation of corrective action plans.  Monitors day-to-day operational activity, providing direction and guidance on workplace matters and direct intervention in emergent situations.

 

Financial Leadership:  In collaboration with upper management, especially CFO of the organization, develops operational budget plan based on data-driven analysis of operational volumes/revenues, operational trends and forecasts,  and efficient use of labor/non-labor expenses required to provide service; routinely monitors actual budget performance against budget plan identifying, identifying adverse trends, drivers of adverse performance and developing effective budget remediation plans. Establish operations standards for cost control, waste reduction, quality, safety, and complete on-time delivery. Monitor utilization patterns of lab services and advises Leadership and other appropriate staff of developing trends in clinical service needs.

 

Quality Leadership:  Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the pre-analytic, analytic, and post-analytic phases of testing. Identifies accreditation and regulatory standards governing operational areas, and assures the processes, policies/procedures and outcomes meet or exceed standards; Identifies evidence-based quality indicators for operational area, develops measures of quality and implements continuous quality improvement processes to achieve benchmark quality outcomes; identifies key customer and employee safety risks, and implements processes,  educational/training interventions, policies/procedures and monitors to mitigate risk of potential harm; provides training to operational employees on quality/process improvement methodology, measures and goals, facilitates quality teams within work area to achieve goals and communicates results to work teams and hospital quality teams.

 

Service Leadership:  Sets and maintains high standards, policies, processes and systems to assure a superior level of customer service, incorporating the needs and concerns of customers into operational objectives and decision-making.  Monitors and communicates service feedback results to work teams.  Utilizes data and feedback as opportunities to educate, train and develop individual and team performance in service to customers.  Establishes and initiates SMART goals and plans to continuously improve service processes and outcomes in operational areas of oversight. 

 

Human Resource/Team Leadership:  Develops and sustains high performing work teams through modeling positive interactions, values-based actions and decisions, and professional behavior; identifies with work teams opportunities to enhance employee engagement and retention, and leads effective implementation of engagement strategies; provides coaching, training and development opportunities for individuals and teams;  manages performance on an ongoing basis, providing corrective counseling, performance improvement plans and discipline on a consistent and equitable basis, as needed; utilizes team behavior-based interviewing to select candidates for employment; finds opportunity to recognize team members and work groups for goal- and value-based performance, and celebrates team accomplishments when meeting milestones and objectives.

 

Regulatory:  Perform other responsibilities as mandated by Clinical Laboratory Improvement Amendments (CLIA) and any other pertinent local, state or federal regulations.

Qualifications

Skills/Qualifications:

  • Oversee staff and manage operating resources
  • Interact effectively with upper management and direct reports using oral and written communication
  • Fast-paced work environment, manage to deadlines
  • Work as part of a team and willingness to collaborate with colleagues
  • Analyze information, problems, situation, practices or procedures
  • Proactive and accountable
  • Acts with a sense of urgency by assuming responsibility, dealing effectively with problems, and exercise good judgment when making decisions
  • Detail oriented, precise and thorough
  • Automated instrumentation experience
  • LC-MS/MS and GC-MS experience
  • Proficient competency of MS Office products

QUALIFICATIONS

Required:

  • MD, PhD or Bachelor’s Degree in Chemistry, Biology, Medical Terminology, or Forensic Science with relevant laboratory experience working in a clinical, forensic, workplace testing, toxicology or related healthcare setting or Master’s Degree in Chemistry, Biology or related sciences.
  • Applicable Professional Membership.

 

Preferred:

  • Experience with Lean and/or Six Sigma laboratory operating practices.

 

Credentials:

  • Specialty certification in toxicology; ABFT or ASCP certification is desirable.

Additional Information

The ideal Clinical Laboratory Director will oversee the operations of their molecular pharmacogenetics laboratory and their clinical toxicology laboratory. The ideal candidate have experience in both a clinical molecular laboratory as well as a urine toxicology laboratory (preferably one that use LCMS testing). The person in this position will play a prominent role and will often serve as the face of the company, so they must have strong communication skills.

Educational bonus, but not required ...

  • MD Pathologist with board certification in Clinical Pathology or/and Anatomic Pathology
  • PhD in Molecular or similar clinical laboratory related field


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