QA Compliance Senior Host Auditor (Clinical Trials)

Job Overview:

Conduct work as identified on the audit activity table related to CDCS (listing on table is not all inclusive but a
representative sample)
♦ Contributes to global QA policies on interpretation/ application of regulations
♦ Provide subject matter expertise to projects Support team in CAPA plan creation
♦ Hosts external audits/inspections e.g. regulatory inspections, strategic clients. Assists with the
facilitation of audit responses
♦ Supports the QA-to-QA relationship with key client(s)
♦ Delivery of training in performance of audits (basic, intermediate, complex)
♦ Participate (for multi-regulatory topics in area of expertise) global Quality initiative(s) aimed at
improving compliance and/or efficiency of the QA organization
♦ Supports 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)
♦ Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated
in applicable controlled documents, are followed
♦ Other duties as assigned by management

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:

♦ 6 years in regulatory environment (experience in GCP roles)
♦ Experience of industry quality systems/standards
♦ Excellent interpersonal/organizational skills, e.g. communication, decision making,
negotiating, problem solving
♦ Able to influence QA strategy systems/standards and ability to apply appropriate regulatory knowledge to multiple scenarios

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