QA Lead Manager (GCP experience)

Job Overview:

Manages CAPAs to resolution
¨ Provides monthly report of activities to Sr. QA Manager/QA portfolio Manager
¨ Oversees timely completion of CAPAs and QIs in QMS
¨ Supports internal and external teams in creation of CAPAs
¨ Maintains good working knowledge of GCP and knowledge of regulatory authority
requirements and inspection support
¨ Interacts with QA Lead Sr. Manager and above as required for quality issue case progression, issue escalations and client notifications.
¨ Supports QA lead Sr. Manager and above in pulling metric data, trending and tracking of Qis for client metrics.
¨ Hosting of external audits/inspections e.g. regulatory inspections, strategic clients
¨ Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed
¨ Perform other duties, as assigned by management


A minimum of a Bachelor's Degree in Life Sciences preferred (or equivalent Life Science experience)
Experience may be substituted for education.


Minimum Required:
¨ 5 years in regulatory environment (experience in GCP roles)
¨ Strong understanding of QMS and CAPA process
¨ Ability to manage client responsibilities
¨ Report and communicates key quality information to Sr. Managers and QA
¨ Able to work effectively within a team environment
¨ Able to communicate effectively during client meetings
¨ Knowledge of GCPs/GxPs

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. For more information about how we collect and store your personal data, please see our Privacy Statement