Madeline Hayes
Senior Specialist, Quality Assurance @Kyowa Kirin, Inc.- U.S.
Signup · Get unlimited contacts
WORK HISTORY
Senior Specialist, Quality Assurance @Kyowa Kirin, Inc.- U.S.
Sanford, NC, US
Provided QA leadership collaborating cross-functionally in the site early-stage activities• Leveraged global VEEVA eQMS to establish and maintain Site QA procedures as applicable to stand up the Site QMS and develop cGxP training requirements for QA Staff• Established a Site Risk Management procedure seeking to ensure a consistently robust and compliant methodology was implemented for the documentation of risk-based approaches and decisions • Lead and coordinated the robust, compliant, and timely implementation of the required Site cGxP procedures in support of the QMS and Contamination Control Strategy• Established procedures for batch record review, product quarantine, and disposition in compliance with applicable regulatory requirements • Provided technical expertise in QA to all cGxP operations within the Manufacturing, Warehouse, Engineering, and Laboratory areas to ensure production targets were achieved compliantly• Ensured compliance with current regulatory requirements for Data Integrity (ALCOA+) as applicable to paper and electronic records• Onboarded, trained, and mentored QA employees and/or contractors per approved staffing plans• Lead and ensured timely investigation of non-conformances, deviations, laboratory exceptions, and other cGxP issues at the site and initiation of CAPA for diligent and effective resolution• Established key performance indicators for Site Quality Metrics including Deviations, CAPAs, Change Controls, OOS, Invalid Assays, OOT, Equipment Failures, EM Data trends, Stability Trends, Product Disposition Cycle-times, etc. • Provided subject matter expertise and leadership to establish a robust culture of quality based on patient-focus, sustainable compliance, and inspection-readiness for all cGxP areas within the facility and laboratory areas
EDUCATION
The University of Akron
Bachelor of Science (BS), Biology, General
Temple University Graduate School
M.S. Regulatory Affairs and Quality Assurance
ABOUT MADELINE HAYES
Quality Assurance Professional with 11+ years of experience in the pharmaceutical/medical device industry with an in-depth understanding and enthusiasm for quality systems and regulatory compliance.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.