Director of Quality and Compliance

Organization
Crescendo Bioscience, Inc.
Job Location
South San Francisco, CA 94080
Job Description

The Director, Quality and Compliance is primarily responsible for:

  • Serving as the Compliance and Privacy Officer ensuring operational compliance to applicable to governmental healthcare regulations and requirements
  • Directing implementation and maintenance of the Quality Management System (QMS) meeting federal/state laboratory regulations;
  • Serving as point and representing the organization/facility to all external entities including customers (pharma collaborators) and regulatory agencies (e.g., CLIA, CAP, NY Department of Health, Notified Bodies, etc.);
  • Leading efforts in regulatory submissions, clinical laboratory certifications/accreditations and international product registrations;
  • Developing its departments to ensure effective quality assurance and regulatory compliance/support during organizational growth

Must have:

  • working with healthcare regulations such as Anti-kickback Statues, Stark Law and False Claim Act
  • experience implementing systems as a covered entity to address HIPAA Privacy Rule
  • previously served as a Compliance or Privacy Officer is a PLUS
  • Collaborative nature
  • Leadership experience – business partner mentality

Prefer to have:

  • experience operating in a clinical lab environment
  • dealing with lab standards/requirements such as CMS CLIA (Clinical Laboratory Improvement Amendments), CAP (College of American Pathologist), NY State (Clinical Laboratory Evaluation Program) or ISO 15189
  • experience facilitating 3rd party audits
  • Served as Management Representative
  • experience working in a small company environment (



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