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 (



Apply Here

How to Apply

At Nature, Johns Hopkins' Gundula Bosch describes her graduate program that aims to get doctoral students thinking about the big picture.

Patricia Fara writes about childcare funding, and women in science and science history at NPR.

National Institute of Environmental Health Sciences researchers have visualized the career paths of former postdocs.

A new survey from the Pew Research Center finds that half of women working in STEM have experienced gender discrimination at work.