QA Compliance Lead Auditor

Labcorp Princeton , NJ 08544

Posted 2 months ago

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)

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.

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 GCP roles)

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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QA Compliance Lead Auditor

Labcorp