What are the responsibilities and job description for the QA Compliance Lead Auditor position at Labcorp?
Job Overview:
Labcorp Drug Development is looking for a Compliance Lead Auditor to join our QA team!
LabCorp Drug Development provides dedicated and fully comprehensive laboratory testing and drug development services to the pharmaceutical industry. We strive to make a difference to people’s everyday lives by bringing essential medicines to the market.
As a key member of the Quality Assurance organization, you will have the following responsibilities (including but not limited to):
-
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. - Facilitates 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:
Preferred:
- A minimum of a Bachelor's Degree in a Pharmacy, Chemistry or Biology related discipline
-
Postgraduate degree (MSG or equivalent) in science or management related discipline,
preferable - Experience may be substituted for education
Experience:
Minimum Required:
8 years in regulatory environment (experience in GXP 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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