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

Education/Qualifications:

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

Experience:

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

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