Lab Director

About the role

PPLM is seeking a Part-Time Laboratory Director to oversee the overall operations and administration of PPLM’s High Complexity Laboratory. This position requires approximately 5-10 hours per week and is hybrid remote, with on-site travel to the Boston laboratory expected at least twice per year (quarterly preferred).

Responsibilities

• Oversee and be actively involved in the overall operation and administration of the laboratory.
• Remain available—onsite, by phone, or electronically—to support laboratory personnel as needed.
• Ensure compliance with all applicable federal, state, and local laws and regulations, including CLIA requirements for high complexity testing.
• Ensure that all duties of a laboratory director, laboratory manager, and assigned personnel are properly performed, and provide clinical supervision as appropriate.
• Ensure the laboratory:
• Develops and implements policies, processes, and procedures to maintain consistent, high-quality testing services.
• Operates under a quality system that ensures accurate, reliable, and timely test results.
• Implements ongoing quality assessment, including monitoring testing processes, identifying and correcting errors, and evaluating the effectiveness of corrective actions.
• Enroll and comply with an HHS-approved proficiency testing program in accordance with CLIA subpart H.
• Ensure testing systems used for all phases of testing (pre-analytic, analytic, post-analytic) are appropriate for the laboratory and patient population.
• Ensure appropriate physical and environmental conditions for testing.
• Ensure a safe working environment for personnel, including adherence to safety and biohazard standards.
• Ensure availability of a qualified general supervisor to oversee day-to-day testing operations and personnel.
• Ensure staffing levels are sufficient and personnel are appropriately trained, educated, and competent.
• Ensure new test procedures are reviewed, included in the procedure manual, and followed by staff.

Requirements

• Must meet CLIA requirements to direct a high complexity laboratory (including 42 C.F.R493.1443).
• Current license issued by the Commonwealth of Massachusetts, as applicable to the role.
• Demonstrated experience and competency in a laboratory environment, including high-complexity testing.
• Strong complex problem-solving skills.
• Excellent written and verbal communication skills.
• Proficiency with laboratory information systems, computer hardware, and automated test instruments.
• Strong organizational skills with the ability to prioritize tasks and follow processes and procedures with accuracy.
• Able to maintain confidentiality and work collaboratively as part of an interdisciplinary team.
• Able to work effectively in a dynamic, high-volume environment and interact professionally with diverse staff, clients, and vendors.
• Able to travel to the Boston laboratory as needed.