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QA Manager (IC)

Company: Labcorp
Location: Durham
Posted on: September 6, 2021

Job Description:

Job Overview:

Labcorp Drug Development is seeking candidates for a QA Manager. The QA Manager will be remotely located (home-based) anywhere within the United States.

 

  • Ensure the consistent implementation, use and review of SOPs.
  • Escalate issues to management in a timely manner implementing appropriate solutions, including preventative actions.
  • Negotiate with functional and operational internal stakeholders to improve quality and increase efficiencies.
  • Analyze and interpret data in order to lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes.
  • Lead and effectively manage constructive crucial interactions with clients or regulatory agencies.
  • Lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes.
  • Interpret applicable quality regulations/standards and create appropriate policies and procedures.
  • Ensure Regulatory Compliance and Quality Assurance (RC&QA) management responsibilities, as indicated in applicable controlled documents, are followed.
  • Perform other duties, as assigned by management.
  • Travel essential to Labcorp Drug Development by Labcorp offices primarily located in Princeton, NJ and Druham, NC with respect to adhering to pandemic restrictions.

Education/Qualifications:

  • A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience).
  • Experience may be substituted for education.

Experience:

  • 8 years in regulatory environment (experience in GCP roles).
  • Experience & regulatory expertise of industry quality systems/standards.
  • Experience with hosting internal, external and FDA audits.
  • Ability to interpret applicable regulations/standards.
  • Experience in leading process improvement initiatives.
  • Ability to communicate and negotiate internal stakeholders effectively.

Keywords: Labcorp, Durham , QA Manager (IC), Other , Durham, North Carolina

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