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Job Details


Labcorp (Drug Development)

QA Lead Sr Manager - REMOTE

Business and Financial Operations

All

Yearly

Full Time

No

Burlington, North Carolina, United States

Labcorp is seeking a fully-remote QA Lead Sr Manager with strong GCP expertise. This is an individual contributor role with responsibility for the following:

  • Contributes in generation of global QA policies on interpretation or application
  • Provides subject matter GCP expertise and influences the ED/CS/CDS organization by providing guidance and client/authority facing support on specific regulatory topics and Quality Issues.
  • Hosting of external audits/inspections e.g. regulatory inspections, strategic clients
  • Supports clients in making regulatory (strategic) decisions/ issue resolution for study problems
  • Manages the QA to QA relationship with assigned key client(s)
  • Participates in client JOC or governance meetings
  • Manages 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) for assigned clients.
  • Provides support to Compliance Lead and Sr. management as a contributor or leader of internal functional QA RCQA initiative.
  • Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed
  • Perform other duties, as assigned by management

Education & Experience:

  • At least 6 years in regulatory environment (experience in GCP roles)
  • Ability to manage client responsibilities
  • Report and communicates key quality information to Sr. Managers and QA
  • Effectively lead and communicate critical issues during client meetings
  • Ability to manage difficult conversations and meetings with clients
  • Detailed knowledge of specific regulations/multiple regulations
  • Ability to influence and negotiate
  • Excellent communication, interpersonal, planning and organizational skills

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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