Director, Global Quality Assurance in Morrisville, NC



$200K - $250K


Quality Management


11 - 15 years

Job Description

Job Overview:

  • Direct, manage, and lead Regulatory Compliance and QA function and staff ensuring that facilities, equipment, personnel, methods, practices, procedures, records, etc. conform to government regulations, ISO standards, ICH GCP guidelines and Covance Policies.
  • Assures QMS compliance to 21 CFR 820, ISO 13485, ISO 14971 and any other applicable regulation (e.g., CAP/CLIA, GLP, GCP).
  • Oversees implementation of regulatory strategy and activities needed to secure clearance and/or approval (IDE, 510(k), PMA) of new in vitro diagnostic medical devices.
  • Anticipates regulatory obstacles throughout product lifecycle while managing preparation and timely submission of regulatory submissions to secure clearance and/or approval.
  • Coordinates and conducts regular Management Review Meetings.
  • Develops and tracks quality metrics.
  • Evaluates the implemented CAPA against trends and quality issues to assess effectiveness.
  • Ens
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Valid through: 2020-1-20

About Covance

Covance Inc. with headquarters in Princeton, New Jersey, is a contract research organization (CRO) providing drug development and animal testing services. According to its website, it is one of the largest companies of its kind in the world, with annual revenues of over $2 billion, and over 15,000 employees in more than 60 countries. It claims to provide the worlds largest central laboratory network. It became a publicly traded company after being spun off by Corning Incorporated in 1996. In 2011 it was listed as one of the top 100 employers by the Diversity Employers Magazine. Under the name Covance Research Products Inc., based in Denver, Pennsylvania, the company also deals in the import, breeding and sale of laboratory animals. It breeds dogs, rabbits, guinea pigs, non-human primates, and pigs, and runs the largest non-human primate laboratory in Germany. The company became the subject of controversy following allegations in 2003–2005 by the British Union for the Abolition of Vivisection and People for the Ethical Treatment of Animals that non-human primates were being abused in its laboratories in Germany and the United States. No violations of the law were found by the authorities in the first case, and a small fine was levied in the second. In response, the company drew up a new welfare code to guide its treatment of laboratory animals. On November 3rd, 2014, Labcorp announced it would be purchasing Covance for $6.1 billion.
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