Senior Director of Laboratory Compliance and Quality
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Senior Director of Laboratory Compliance and Quality

Glen Allen, VA

At GENETWORx Laboratory, we improve the health and wellness of lives around the world through dedicated research, experienced scientists, 21-st century technology, and in-depth diagnostics. Healthcare is personal and as such, the future needs to be, too. By intersecting genetic testing with personalized medicine and pharmacogenomics, we’re positioning our patients and empowering physicians with more precise, individualized, effective results.
As a leader in precision COVID-19 testing, GENETWORx provides unparalleled support, results, and clarity during these uncertain times. GENETWORx has armed healthcare providers, employers and universities with rapid and accurate COVID-19 diagnostic and antibody testing which is essential for reopening businesses and communities.

Summary

The Senior Director of Laboratory Compliance and Quality provides leadership and direction to organization-wide compliance, quality and safety programs, focusing efforts on outcomes which improve the quality of patient testing, advances overall safety and satisfaction within the organization, promotes efficient delivery of test results and reduces risk across the organization. The Senior Director of Laboratory Compliance and Quality provides oversight and guidance to all members of the Compliance and Quality Department, assists the Operations team in identifying compliance risks and in implementing plans to monitor, and also works closely with government agencies, internal and external legal counsel to ensure compliance with current laws. The person in this role must be a results-driven team player who treat patients as if they were their own family members.

Responsibilities

  • Serve as a member of the Executive Leadership Team
  • Lead the development of a culture of Quality in accordance with Medicines & Healthcare products Regulatory Agency (MHRA), Food & Drug Administration (FDA) and aligns with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
  • Partner with company Leadership to identify strategies and solutions that drive quality initiatives, create a culture of process excellence, and execute process improvement activities establishing a scalable growth platform with quality and service levels that are best-in-class
  • Implementation of policies, processes, and training improvements
  • Improve quality through the development, ongoing monitoring and remediation of KPIs
  • Manage the coordination, initiation, investigation, correction, and closure of laboratory Quality Issues (QIs) and the execution of Corrective and Preventative Actions (CAPA)
  • Lead all internal and external quality audit activities, to include customer audits, regulatory audits, and qualification audits of 3rd party service providers
  • Achieve annual operational excellence objectives by leveraging continuous improvement tools, training, and initiatives
  • Hire, lead, coach and develop a team of quality assurance and process improvement professionals

Qualifications

  • Masters Degree in Healthcare Administration, Business Administration or Compliance/Legal
  • Minimum of 10 years' experience in Laboratory Compliance and Quality
  • Risk Management and audit experience preferred
  • Proficiency in collecting and analyzing compliance processes, work flows, and control relationships
  • Knowledge of CAP, CLIA, FDA and EPA standards a must

Compensation: TBD

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