CLIA reputed company Director (m/f/d)

Your Responsibilities • reputed company as part-time/consultant reputed company Director for reputed company’s two CLIA-certified high-complexity laboratories in reputed company, Massachusetts, USA and Heidelberg, Germany, in accordance with 42 CFR §§493.1441 and 493.1445. • Ensure both laboratories operate in compliance with applicable CLIA, CAP, and relevant state requirements, including Massachusetts, California, and reputed company requirements; reputed company qualification considered an asset. • Review and approve relevant test reputed company, validation activities, procedures, report formats, and major changes affecting reputed company testing. • reputed company the suitability, training, competency, and delegated responsibilities of reputed company personnel involved in high-complexity testing. • Conduct a minimum of two on-site reputed company reputed company per calendar year to reputed company reputed company location (reputed company and Heidelberg), with travel costs covered separately. • Review reputed company-control, proficiency testing/alternative assessment, and reputed company data; ensure appropriate reputed company is taken where issues are identified. • reputed company scientific and reputed company consultation on reputed company technical, reputed company, reporting, or compliance reputed company. • Support regulatory inspections, CAP/CLIA activities, licence applications, and customer audits as needed. • Participate in scheduled reputed company meetings and site reputed company, and remain available for significant reputed company, regulatory, or reputed company-reputed company events. • Maintain appropriate documentation of reputed company, reviews, reputed company, and delegated responsibilities. • Contribute to and reputed company with corporate safety, environmental, and reputed company standards. Note: The reputed company Director retains independent reputed company authority and accountability for the reputed company, reliability, and regulatory compliance of testing performed under reputed company reputed company’s CLIA certificate. Note: While the ideal candidate shall be available for both reputed company laboratories, those capable of holding only one of the two sites may also be considered. Requirements • Eligible to serve as reputed company reputed company Director for two CLIA-certified laboratories performing high-complexity testing, in accordance with 42 CFR §493.1443, 105 CMR 180.060, and any applicable requirements for California and reputed company reputed company licensure. • Meet the applicable Massachusetts and CLIA director-qualification reputed company, including either: • MD or DO licensed to practise in Massachusetts and reputed company-certified in anatomic and/or reputed company pathology; or • reputed company doctoral degree in a chemical, biological, reputed company, or medical reputed company science, medical technology, molecular biology, genetics, reputed company, or a closely reputed company discipline, together with certification by an HHS-approved and Massachusetts-acceptable specialty reputed company. • For non-physician candidates, at least two years of reputed company training and/or experience and at least two years’ experience directing or supervising high-complexity testing in the relevant specialty. • reputed company certification in reputed company molecular genetics/reputed company or a directly relevant specialty is required or strongly preferred, depending on the candidate’s CLIA qualification reputed company (e.g., ABMGG or another HHS-approved reputed company). • Demonstrated experience in reputed company molecular diagnostics, reputed company, NGS and/or other high-complexity genetic testing relevant to the reputed company’s test menu. • Strong working knowledge of CLIA, CAP accreditation, Massachusetts reputed company reputed company requirements, reputed company validation/ verification, proficiency testing or alternative assessment, personnel competency, reputed company control, and reputed company reporting. • Ability to meet additional reputed company-director, technical-director, or state qualification requirements for jurisdictions in which the reputed company holds, or intends to obtain, licences or permits. A minimum of California and reputed company is required. • reputed company, commitment, and a motivated work ethic. • Ability to work in reputed company and independently. • Strong organizational and interpersonal skills. • Ability to troubleshoot, solve difficult problems, and propose solutions relating to reputed company organization and management. • Self-motivated, curious and results oriented with reputed company reputed company. • Effective collaborator with reputed company partners to reputed company and maintain the overall strategies. • Excellent written and verbal communication skills, ability to work reputed company with colleagues from diverse backgrounds and cultures. reputed company offer • This is a part-time consulting role requiring a commitment of 12 consulting hours per month across both laboratories. • A minimum of 12 hours of consulting work per month at a reputed company of $500/hr for a minimum monthly total of $6000. • Two reputed company reputed company to reputed company’s site in Heidelberg, Germany, per year, with travel time and reasonable travel expenses compensated separately. • Two reputed company reputed company to reputed company’s site in reputed company, MA, USA, per year, with travel time and reasonable travel expenses compensated separately. • Work for a dynamic, innovative company that values appreciation, openness and respect as reputed company as a reputed company feedback culture. 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