Aoife McKeon
Clara
Summary
Accomplished Director of Quality Management at Cardinal Health, adept in regulatory compliance and quality management. Spearheaded successful global audits and enhanced supplier management processes, driving significant operational improvements. Recognized for talent development and cross-functional collaboration, consistently achieving project goals while fostering a culture of excellence.
Overview
22
22
years of professional experience
Work History
Director QA/ RA
Enterasense Ltd
Galway, Ireland
12.2024 - Current
- Responsible for leadership of QA/RA Team
- Quality Management System Oversight
- PRRC & Management Representative
- Handling Technical Documentation submission required for CE marking of medical devices.
Director, Quality Management
Cardinal Health
Tullamore, Ireland
08.2022 - 10.2024
- Directed corporate compliance group, ensuring consistent oversight of global manufacturing and distribution sites through QMS and FDA & DEA simulation audits.
- Designed strategies for talent advancement and performance evaluation.
- Conducted gap assessments to ensure adherence to standards and regulations.
- Designed and executed quality plans to target improvement areas.
- Led FY24 priorities project for QRMA Organization.
- Directed project goals for on-time completion, leading directors effectively.
- Offered compliance assistance for the Supplier Management team regarding contract manufacturing and private brand suppliers.
- Demonstrated expertise in MDSAP, 21 CFR Part 820 regulations.
- Enhanced quality systems through ongoing process updates.
- Escalates and communicates matters of urgency to senior leaders, to ensure continued compliance to regulatory requirements
- Improved efficiency and savings through the implementation of a risk-based strategy to auditing, and by combining processes.
- Provided inputs into periodic reviews, design files, trend reports, and management review.
- Partnered with cross functional stakeholders globally to drive improvements and support projects
- Voice of Employee (VoE) action plan implementation
- Oversaw organisational budget within the corporate compliance division.
- Facilitated targeted sessions on CAPA, MDSAP and auditing processes for skill development.
- Played an essential role in the Diversity, Equity & Inclusion Council.
- Spearheaded the Quality Begins with Me (QBWM) initiative in the pharmaceutical division.
Quality Ops and Compliance Manager
Cardinal Health
Tullamore, Ireland
01.2018 - 08.2022
- Standardized procedures and policies in collaboration with shared services and manufacturing site teams across the organization.
- Implemented continuous improvements by effectively using established procedures and records.
- Manages enterprise-wide projects, streamlining operations and engaging with top executives.
- Executed projects like 1QMS, Supplier Remediation and eQMS.
- Encouraged groups to embrace impactful changes within mission scope.
- Fostered collaboration between shared services and manufacturing locations to ensure compliance.
- D E & I Gen Next Team Member
- D E & I Liaison for EMEA
- Handled both Tier I and Tier II audits efficiently.
- Subject Matter Expert for External Audits (supporting Tier I and Tier II audits where applicable)
- Resolved process, product, and system issues in manufacturing facilities.
- Directed comprehensive CAPA strategies across multiple sites.
- Conducted benchmarking of top-tier processes to aid continuous improvement.
- Coordinated and monitored all Quality KPI’s for Operations Quality group including completion of monthly reports.
Sr Quality Systems Supervisor
Cardinal Health
Tullamore, Offaly
07.2017 - 01.2018
- Managed supplier quality team and processes including incoming inspection, vendor approval, and monitoring.
- Directed QA team's leadership, career development, and performance management.
- Adhered to regional and corporate guidelines along with regulatory standards.
- Conducted internal audits to ensure compliance.
- Served as expert on site risk management.
- Conducted deployment of First Time Quality (FTQ) events.
Quality Engineer
SteriPack Ltd
Clara
08.2007 - 06.2014
- Performed internal audits & external (supplier audits)
- Facilitated on-site customer audits annually amounting to approximately 40 audits.
- Spearheaded quality engineering for electronics, needles, and implantable devices in contract manufacturing.
- Managed supplier relationships through oversight, qualification processes, and performance monitoring.
Plant Microbiologist
Covidien
Tullamore, Ireland
02.2004 - 08.2007
- Directed leadership, career development and succession planning for laboratory personnel.
- Directed operations of Microbiology laboratory.
- Ensured continuity of tasks during absence of Sterilization Supervisor.
Lecturer (Pro Rata)
Environmental, Health & Safety Risk Management Service
Ahtlone , Westmeath
09.2003 - 02.2004
- Delivered lectures on Environmental & Occupational Hazards to adult learners under the BSc curriculum for Environmental Health & Risk Management Systems at Athlone IT.
- Conducted educational tutorials.
- Developed and refined academic assessments.
- Updated educational resources by refining course materials.
Education
M.D. - Medical Device Technology Regulatory Affairs
National University of Ireland, Galway
Ireland11.2019
BSc - Science (Hons)- Microbiology
National University of Ireland, Galway
01.2003
National Diploma - Health & Leisure Science
Tralee Institute of Technology
Tralee, Kerry01.1998
National Certificate - Health & Leisure Science
Tralee RTC
Tralee, Kerry01.1997
Skills
- Quality management
- Regulatory compliance
- Technical documentation
- Audit management
- Project management
- Cross-functional collaboration
- Risk assessment
- Talent development
- Supplier management
Accomplishments
- D E & I Council Member
- Listening Volunteer for Samaritans Ireland
- Pharmaceutical Quality Systems (PQS) Lead Auditor Certified
- Lead Auditor ISO 9000 trained (IQC)
- MDSAP trained
- ISO14971 Trained (SQT)
- IMDA Diagnostic Leadership Programme completed (ILM)
Affiliations
- Jogging
- Gardening
- Mini model craft
Timeline
Director QA/ RA
Enterasense Ltd
12.2024 - Current
Director, Quality Management
Cardinal Health
08.2022 - 10.2024
Quality Ops and Compliance Manager
Cardinal Health
01.2018 - 08.2022
Sr Quality Systems Supervisor
Cardinal Health
07.2017 - 01.2018
Quality Engineer
SteriPack Ltd
08.2007 - 06.2014
Plant Microbiologist
Covidien
02.2004 - 08.2007
Lecturer (Pro Rata)
Environmental, Health & Safety Risk Management Service
09.2003 - 02.2004
M.D. - Medical Device Technology Regulatory Affairs
National University of Ireland, Galway
BSc - Science (Hons)- Microbiology
National University of Ireland, Galway
National Diploma - Health & Leisure Science
Tralee Institute of Technology
National Certificate - Health & Leisure Science
Tralee RTC
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