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QA Compliance Lead Auditor, GCP-CDCS

Location
Durham, North Carolina
Job Type
Permanent
Posted
23 Sep 2022

Labcorp Drug Development is hiring for QA Compliance Lead Auditor, with seasoned background in GCP (preferred experience in GCP hosting) and regulatory policies. This is a remote US based opportunity ( with preference for candidate located in or near Durham, NC or Princeton, NJ ).

Ideal candidate is looking to increase leadership, continue to enhance day-to-day work specific to GCP/hosting, and in regulatory and must be detail oriented with strong communication skills.

What to Expect:

Job Responsibilities include but not limited to:

? Takes lead in generation of global QA policies on interpretation/application of regulations
? Provide subject matter expertise and leads/influences the CDS organization by providing guidance and client/authority facing support on specific niche regulatory topics
? Hosts (ie for cause inspection, non-standard authority inspections, country-specific or scope of inspection) external audits/inspections eg 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 (eg 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

Travel Expectations:

Travel to LDD facilities (Durham, NC and/or Princeton, NJ) may be required to host/support onsite client audits/regulatory inspections (~20%); most audits may be hosted remotely

Qualifications/Experience:

? 8 years in regulatory environment (experience in GCP roles)
? Regulatory expertise - detailed knowledge of specific regulation/multiple regulations
? Experienced Lead Host
? Strategic communication with clients
? Experience leading process improvement initiatives

Qualifications/Education:

? 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.

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Details

  • Job Reference: 719268206-2
  • Date Posted: 23 September 2022
  • Recruiter: LabCorp
  • Location: Durham, North Carolina
  • Salary: On Application
  • Sector: I.T. & Communications
  • Job Type: Permanent