Microbiology CLIA Director, Molecular Focused

GENERAL JOB DESCRIPTION

The CLIA Microbiology Director shall:

• Support Eurofins Donor & Product Testing business philosophy, leadership values and ethics.
• All employees are expected to meet basic expectations of DPT’s quality management system, including, but not limited to good workmanship, adherence to standard operational procedures, training, good documentation practices, accurate recordkeeping so the company may meet its stated quality policy and objectives.
• Responsible for the development and execution of the laboratory structure and organization at each site.
• CLIA regulations require a high complexity laboratory to have a Laboratory Director available to oversee the overall operation and administration of the laboratory
• Responsible for the development and execution of the laboratory structure and organization
• Maintain continuous lab operations with integrity and validity for all laboratory activities
• Responsible for oversight of the Microbiology laboratory leadership team to ensure timely delivery of quality test results, will interact with customers, provide strong technical leadership, and collaborate effectively across groups within the organization

ROUTINE BUISNESS OPERATIONS

• Oversees and directs Eurofins DPT Microbiology and Sterility Management
• Focus on strengthening individuals and their capabilities to build a leadership pipeline
• Maintain quality accuracy and ensure all quality monitors meet laboratory objectives
• Enforce applicable policies and procedures throughout the entire laboratory operation
• Develops, implements & enforces laboratory policies, procedures & performance standards affecting wide range of customer entities (Organ Procurement Organizations, Tissue Banks, etc.)
• Work directly with the Director of Laboratory Operations to plan, develop, and drive the vision and strategy of this laboratory to meet the company’s set objectives
• Participates in developing new methodologies & tests and develops strategic planning initiatives
• Oversees all laboratory testing and provides scientific expertise to staff for all human related specimens
• Reports critical information to Executive Team, as needed
• Demonstrates passion and enthusiasm for the company's vision, and motivates, leads, and empowers others to achieve company goals
• Evaluate automation of current and new testing platforms based on the needs and capacity of the department
• Plan and have oversight of the implementation of new instrumentation to increase efficiency of laboratory processes
• Recommends new technology/equipment for the laboratory and works within DPT's budget cycle
• Establishes quantitative financial metrics by which the laboratories efficiency and effectiveness can be evaluated; identifies opportunities for improvement (Consumables/personnel as a % of revenue)
• Ensures timely review and approval of all laboratory procedure and safety manuals, review and approval of all proficiency testing results (before submission to vendor and upon receipt of evaluation report) demonstrated by comments, signature/date
• Ensures an annual review of training and competency files and corrective action plans/reports demonstrated by comments, signature/date
• Continuous staffing model assessment and oversight of headcount for the Microbiology department
• Evaluates department personal headcount structure and can prepares justifications for additions
• Ensure that prompt corrective action is taken for all lab audit findings or deficiencies noted
• Serve as a laboratory departmental liaison during regulatory inspections and/or client audits
• Consistent communication with Executive Leadership to ensure they are aware of relevant matters
• Responsible for maintaining suitable staffing levels throughout the lab and satellite locations and provides continuous feedback and training; ensures that staff is qualified and cross-train microbiological staff to provide consistent and timely services
• Ensure that the laboratory passes all audits and maintains appropriate regulatory status
• Ensure adherence to regulatory standards and safety requirements. Understand and stay updated on regulatory requirements for the industries we service (i.e. CLIA, FDA, TGA, etc.).
• Stays abreast on all Quality Event Management items (complaints, deviations and corrected reports, SCARs, CAPAs)
• Plans, direct and manage the Sterility and Microbiology Laboratory in all activities related to Microbiology testing to include proper testing, reporting results, test interpretation, development of test methodologies, setting of standards & certification of tests meeting CLIA/CAP certification requirements &/or other state & federal guidelines
• Considerable knowledge of the methods, materials, and techniques used in laboratory work with the ability to aid in trouble shooting of technical problems
• Implements policies and procedures that will improve day-to-day operations
• Excellent presentation skills
• Exceptional cross-functional team leadership skills and ability to work in close collaboration with others
• Strong organizational and planning skills as well as strong attention to detail
• Ability to work independently with limited supervision, adapt to change and manage multiple tasks
• Ability to problem-solve and make decisions on complex issues, often in a cross-functional team setting
• Critically reviews laboratory key performance indicators/quality assurance indicators/reactive rates
• Build and maintains relationships with Director of Business Development and Account Executives to make decisions regarding operational activities and goals
• Handles discipline and termination of employees as needed and in accordance with company policy
• Conducts performance evaluations that are timely and constructive
• Creates and executes on department strategy with support of Director of Laboratory Operations
• Participates in the hiring and training of managers, supervisors and leads
• Counsels Microbiology management regarding problems encountered in daily operations
• Communicates and explains new directives, policies, or procedures to managers; for major changes, meets with entire operations staff to explain changes, answer questions, and maintain morale