Aidan Casey
Senior Manager, Global Commercial and Distribution Quality Assurance @Abbott
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WORK HISTORY
Senior Manager, Global Commercial and Distribution Quality Assurance @Abbott
London, GB
Multi-site (48) responsibility for supporting the Abbott Laboratories in-country commercial affiliate compliance and Quality System programs across the globe. The core responsibilities of this role include: Lead Inspection Readiness of all in-country commercial affiliates, consisting of conducting pre-inspection audits, on-site inspection support, as well as post-inspection activities. Develop, implement, and maintain a robust QMS in compliance with international regulatory requirements, including multi-divisional harmonization of existing quality systems. On-market distribution controls, including internal and third party cold-chain logistics warehousesCold chain warehouse qualifications, including both passive and active shippers. Quality System consulting relating to Investigations, CAPA, Change Management, Training, Document Management, Management Review/KPI measurements and Supplier Quality Conduct internal and supplier audits
EDUCATION
Seton Hall University School of Law
Healthcare Compliance, Ethics & Regulation Certification Program
Munster Technological University
Bachelor of Engineering , Electronic Engineering
University College Cork
MSc in Technology Management
SKILLS
ABOUT AIDAN CASEY
Senior quality assurance and regulatory compliance professional in the Medical Device and In-Vitro Diagnostic industries with extensive inspection readiness, quality system management, compliance and audit program development experience working on 21 CFR 820, NMPA (China), ISO 13485, IVDR, MDR, PMDA (Japan), ISO 9001 and ISO 14001 standards. • Global multi-site management experience providing compliance management, quality system harmonisation, contract manufacturer (CMO) risk mitigation, FDA inspection readiness activities, and execution of the internal audit plan. Experienced in directing site remediation efforts in relation to FDA Consent Decree and Corporate Warning Letters• Responsible for the compliance and audit programs of 7 manufacturing (Instrument and Biologics), 48 commercial affiliate sites, and in excess of suppliers and contract manufacturers worldwide. Oversee the performance of simulated inspections and contribute to the determination of site inspection readiness. • Experience in relation to third party audit and FDA inspection management• Contract Manufacturer quality system development experience and management of remediation projects for pre-approval FDA inspections of CMO’s located in USA and Asia. • Excellent communication and interpersonal skills• Global virtual team management experience • Knowledgeable in Healthcare Compliance relating to monitoring, internal investigations and commercial training development. Anti-corruption laws (FCPA / UK Bribery Act), third-party risk, anti-trust/competition law, pharmaceutical industry codes (ABPI / EFPIA), data privacy
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