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Corporate Compliance Manager

Company: Staffing Theory
Location: Durham
Posted on: February 23, 2021

Job Description:

Pharmaceuticals - GxP Regulations - Regulatory Audits - QMS
Corporate Compliance ManagerWe have a client based in Research Triangle Park, North Carolina, seeking a Corporate Compliance Manager. Requires knowledge of Pharmaceuticals, GxP Regulations, Regulatory Audits and QMS.
The Corporate Compliance Manager is responsible for maintaining all records associated with Sponsor audits, technical audits, and scientific visits.
Essential Responsibilities

  • Represents the QMS function during Regulatory/Sponsor quality audits, technical audits, and scientific visits
  • Maintains records, schedules, and lists as appropriate for all Sponsor audits, technical audits, and scientific visits
  • Leads, schedules, manages, and closes all Sponsor audits for the Durham site
  • Collaborates with Operations and IT teams to provide appropriate responses to Sponsor audits, in a timely manner
  • Works with the Business Development team on completing RFIs (Request for Information) from current and potential Sponsors
  • Maintains Company Profile Questionnaire, including but is not limited to collaborating with other departments to ensure information is current
  • Provides training-related or other input for audits and inspections as assigned
    Minimum Acceptable QualificationsEducation/Experience:
    • Bachelor's degree in biology, chemistry, other scientific or related discipline
    • Not less than eight (8) years of experience in pharmaceutical, biotech, or support organization
    • Strong, working knowledge of GxP regulations
    • Strong experience in a QMS function
      Not Remote. Visa Support. Paid relocation available from within the US.
      We look forward to hearing from you!

Keywords: Staffing Theory, Durham , Corporate Compliance Manager, Executive , Durham, North Carolina

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