SQAFYI - Software QA Resource - FYI

US: Corporate QA Project Manager

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 03-Dec-2014

Corporate QA Project Manager

Assist plants in conducting and documenting investigations as required, through remote and/or onsite support as assigned Perform FDA Establishment Registrations (Drug, GDUFA, Device, Food, Tissue, Tobacco) Read and interpret FDA regulations regarding establishment registrations and listings

Coordinate projects as needed that may arise from regulatory changes Perform registrations for local US based licenses and permits Coordinate and lead global QA and QA/Operations webinars monthly Implement best practices, conduct training and mentor others in CAPA, Risk Management / FMEA, and other quality processes as assigned Develop and implement process improvements and train the cross-functional teams / global organization on use Create and revise procedural documents (WI, SOP, Job Aid) using an electronic change control system Identify and manage continuous improvement projects with the objective of achieving quality / reliability goals, process efficiencies and cost improvements Collect and compile QA metrics for the Corporate Management Review process, continuous improvement initiatives and other periodic quality assessments May independently perform or contribute to global Corporate and Site level Internal Audits Regular attendance is mandatory


Bachelor's Degree in a technical discipline Seven plus (7+) years of experience in the pharmaceutical or medical device industry in a quality assurance role Project Management experience is required Risk Management / FMEA expertise is required Proven track record for identifying and implementing continuous improvements Excellent verbal and written communication skills Proven success working hands-on with multifunctional, global teams Demonstrated data analysis, problem solving and CAPA documentation skills

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Thank you,
Team SQAFYI - Software QA Resource FYI

US: Corporate QA Project Manager