05/05/2026 updated
RK
100 % available
Quality Systems Leader | QMS Implementation & Technical Platform Expert
Carrigaline, Ireland
Worldwide
Master of Business AdministrationQuality Management Systems (QMS)
17+ years of progressive experience in implementing and managing Quality Management Systems in GxP regulated environments, including Veeva Vault QMS and TrackWise, with expertise in system configuration, data migration, and inspection readiness.
Technical Platform Leadership
Extensive background as Technical Platform Lead and SME for Veeva Vault architecture, covering platform configuration, data model alignment, performance optimization, and integration of AI/ML features to enhance operational efficiency.
Data Migration & Harmonization
Proven track record in large-scale data harmonization and migration, including the migration of 1 million+ records from TrackWise to eQMS, delivered on time and within budget, as well as harmonization of site-based QMS applications into single global instances.
Business Process Ownership
Strong capability in owning and improving business processes, authoring and approving Business SOPs, training plans, and validation deliverables across cross-functional teams.
Risk Management, RCA & CAPA Execution
Solid expertise in risk management, root cause analysis, and CAPA execution within regulated pharmaceutical and biologics environments.
Cloud Hosting (AWS)
Certified AWS Practitioner and Developer Associate with hands-on experience migrating QMS applications from on-premises infrastructure to AWS cloud environments.
Project Management
Experienced in managing QMS projects end-to-end, including defining and reporting project-level KPIs, cross-functional governance, risk and dependency management, and reporting to PMO teams.
DevSecOps & Continuous Validation
Championed DevSecOps practices by integrating continuous validation and automated testing into the Veeva delivery pipeline, ensuring compliant and efficient software delivery.
Quality Metrics, KPI Monitoring & Dashboarding
Skilled in defining, monitoring, and reporting quality metrics and KPIs to senior stakeholders including Site Directors, Executive Directors, and Vice-Presidents.
SAFe Agile
Familiar with SAFe Agile methodology, applying agile principles to quality system implementation and continuous improvement initiatives.
17+ years of progressive experience in implementing and managing Quality Management Systems in GxP regulated environments, including Veeva Vault QMS and TrackWise, with expertise in system configuration, data migration, and inspection readiness.
Technical Platform Leadership
Extensive background as Technical Platform Lead and SME for Veeva Vault architecture, covering platform configuration, data model alignment, performance optimization, and integration of AI/ML features to enhance operational efficiency.
Data Migration & Harmonization
Proven track record in large-scale data harmonization and migration, including the migration of 1 million+ records from TrackWise to eQMS, delivered on time and within budget, as well as harmonization of site-based QMS applications into single global instances.
Business Process Ownership
Strong capability in owning and improving business processes, authoring and approving Business SOPs, training plans, and validation deliverables across cross-functional teams.
Risk Management, RCA & CAPA Execution
Solid expertise in risk management, root cause analysis, and CAPA execution within regulated pharmaceutical and biologics environments.
Cloud Hosting (AWS)
Certified AWS Practitioner and Developer Associate with hands-on experience migrating QMS applications from on-premises infrastructure to AWS cloud environments.
Project Management
Experienced in managing QMS projects end-to-end, including defining and reporting project-level KPIs, cross-functional governance, risk and dependency management, and reporting to PMO teams.
DevSecOps & Continuous Validation
Championed DevSecOps practices by integrating continuous validation and automated testing into the Veeva delivery pipeline, ensuring compliant and efficient software delivery.
Quality Metrics, KPI Monitoring & Dashboarding
Skilled in defining, monitoring, and reporting quality metrics and KPIs to senior stakeholders including Site Directors, Executive Directors, and Vice-Presidents.
SAFe Agile
Familiar with SAFe Agile methodology, applying agile principles to quality system implementation and continuous improvement initiatives.
Languages
EnglishNative speaker
Project history
Partnered in the implementation and optimization of Veeva Vault QMS, aligning system configurations with global regulatory requirements and business objectives. Led a team of technical experts in system integrations, ensuring seamless data flow between Veeva platforms and enterprise systems. Acted as technical SME for Veeva Vault architecture, offering consultative leadership on platform configuration, data model alignment, and performance optimization. Partnered in large-scale data harmonization and migration of 1 million+ records from TrackWise to eQMS. Integrated AI/ML features into Veeva Vault and championed DevSecOps practices including continuous validation and automated testing.
Site SME for implementing business applications and lab systems. Collaborated with Quality Assurance, Quality Control, Manufacturing, Validation, CSQ, and Global teams to meet defined targets. Authored, reviewed, and approved Business SOPs, training plans, and validation deliverables. Drove UAT/FAT and acceptance testing, aligned with global teams for system harmonization, and reported system rollout status to Site Directors, Executive Directors, and Vice-Presidents.
Consultant role focused on harmonization of all site-based QMS applications into a single global instance. Responsibilities included team leading, effort coordination, defining and reporting project-level KPIs, cross-functional governance, risk and dependency management, identifying best practices, and reporting to the PMO team on status, challenges, and risks.