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Labcorp QA Compliance Lead Auditor (GCP) in Helana, Montana

Job Overview:

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

  • Conduct work as identified on the audit activity table (listing on table is not all inclusive but a representative sample)

  • Takes lead in generation of global QA policies on interpretation/ application of regulations

  • Provide subject matter expertise and leads/influences the ED/CS/CDS/CLS organization by providing guidance and client/authority facing support on specific niche regulatory topics

  • Hosts (i.e. for cause inspection, non-standard authority inspections, country-specific or scope of inspection) external audits/inspections e.g. regulatory inspections, strategic clients.

  • Facilities and reviews responses to the audit.

  • Leads the reporting of quality metrics and implementation of necessary corrective actions and/or process improvements via appropriate forum (e.g. Monthly Reports, Site Quality Review, Liaison meetings).

  • Manage (for own area of expertise) / participate (for multi-regulatory topics) in broad scope global Quality initiative(s) aimed at improving compliance and/or efficiency of the QA organization

  • Acts as a backup for QA Manager; provides monthly report of activities to QA Manager; performs other related duties as assigned

  • Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed

  • Other duties as assigned by management.

  • Regional travel essential with respect to adhering to pandemic restrictions.

Education/Qualifications:

  • A minimum of a Bachelor’s Degree in a Pharmacy, Chemistry or Biology related discipline.

  • Postgraduate degree (MSC or equivalent) in science or management related discipline, preferable.

  • Experience may be substituted for education.

Experience:

  • 8 years in regulatory environment (experience in GXP roles).

  • GCP Phase II/IV experience: investigator site audits, vendors, project, process audits.

  • Regulatory expertise - detailed knowledge of specific regulation/ multiple regulations.

  • Experienced Lead Auditor.

  • Strategic communication with clients.

  • Experience leading process improvement initiatives.

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