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Director, Laboratory Services
hace 3 semanas
**Director, Laboratory Services**
**Job Purpose/Summary**
Responsible for providing effective clinical leadership for the development and delivery of global laboratory services and products. This position is responsible for clinical oversight of all laboratory operations, assuring that such operations are conducted in compliance with applicable regulations.
**What You’ll Do**
Laboratory Oversight & Administrative
- Provide effective and efficient administrative direction of the laboratory, including budget planning and controls in conjunction with the individual(s) responsible for financial management of the laboratory.
- Ensure that qualified personnel are employed; by defining the qualifications and responsibilities of all laboratory technical staff and documenting training and/or competency.
- Specify in writing the technical and administrative responsibilities and duties of all laboratory personnel.
- Ensure all technical staff has current and up to date licensing and credentials.
- Delegate the responsibilities of the Laboratory Supervisor, Specialty Laboratory Directors/Supervisors, Quality Control Manager and Testing Personnel to employees who are qualified to perform such duties.
- Responsible for designing, validating, and maintaining the technical accuracy and medical reliability of the laboratory test.
- Monitor all work performed in the laboratory to ensure that clinically reliable data are generated and efficiently reported.
- Participate in the selection of partner laboratories.
- Ensure that a supervisor provides onsite supervision of high complexity test performance.
- Act as operations representative for regulatory interactions that include FDA/CLIA/CAP/EMA, etc
- Oversee and maintain relevant laboratory testing and reporting, laboratory and clinical trial files and other laboratory documentation to ensure inspection readiness at times.
- Lead the development and continuous improvement of laboratory SOPs, and GLPs and provide oversight of laboratory quality & adherence to established processes and plans.
- Review and approve laboratory documentation such as policies and procedures, validation plans and reports, training and competency assessments, and reagent/control/instrument qualifications, quality audits, deviation approval requests, and nonconforming event reports.
- Maintain an effective working relationship with applicable accrediting and regulatory agencies.
- Subject Matter Expert for client interactions and business development activities
- Report all concerns of test quality and/or safety to Vice President, Global Laboratory Services.
Laboratory Quality Management System (QMS)
- Working with the Manager Quality Assurance to support and enforce all aspects of the laboratory’s QMS to ensure conformance to requirements described in the Quality Management System and Clinical Laboratory Practice Standards including management of outcomes and non-conformities, participation in internal quality control system monitoring, and performance in proficiency testing.
- Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of Clinical Laboratory Services provided and to identify failures in quality as they occur.
- Assure that laboratory participates in monitoring and evaluating the quality and appropriateness of services rendered, within the context of the Quality Management System, regardless of where the testing is performed.
- Ensure that the laboratory is enrolled in the appropriate proficiency testing program for the testing performed.
- Effectively implement a plan of correction to deficiencies identified.
- Perform and document monthly quality audits of all testing equipment to ensure optimal accuracy and performance.
Laboratory Information Management System (LIMS)
- Working with the IT Manager in selection, implementation and management of LIMS
Personnel Management
- Ensure that policies and procedures are established for monitoring staff to assess competency, and whenever necessary, provide remedial training or continuing education to improve skills.
- The laboratory director is responsible for competency assessment of direct-report supervisors; Documentation of assessments must be performed regularly and whenever new systems are introduced; Remedial steps must be documented when staff does not perform as expected.
- Provide continuing educational to laboratory technical staff that is relevant to laboratory medicine.
- Ensure that an approved procedure manual is available to all personnel.
Environment, Health & Safety
- Promote a safe laboratory environment for personnel and the public
**What You Bring**
- A Medical Degree (MD) or Doctoral degree (PhD) in clinical laboratory science, chemical, physical, or biological science that meets the requirements to be a High Complexity Laboratory Director under CLIA/CAP.
- 7-10 years’ experience as a Laboratory Director with administrative responsibilities
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