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Labcorp QA Audit Manager- (GCP) in Topeka, Kansas

Job Overview:

  • Oversees designated global audit programs for compliance to the master audit plan (procedures, execution, QC, compliance to process, etc.)

  • Identifies the scope and leads global audits and associated audit team

  • Facilitates prioritization of global projects for risk-based audits

  • 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

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 a GCP regulatory environment.

  • 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.

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