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QA Lead Manager - REMOTE

Indianapolis, Indiana, US
Closing date
Jan 15, 2022

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Consultancy/Private Sector
Conservation science
Salary Type
Employment Type
Full time
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Job Overview: The QA Lead Manager role consists of the following reponsibilities: * 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 authorityrequirements 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. * Hosts external audits/inspections e.g. regulatory inspections, strategic clients * Ensures Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed * Performs 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: 5 years in regulatory environment (experience in GXP roles, specifically Clinical) 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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