Data Integrity Program Lead

Location: Hybrid, Waterford, Ireland

Company

hirify.global is hiring for a data integrity leadership role supporting a regulated manufacturing environment.

What you will do

• Develop and implement the site Data Integrity strategy, governance framework, roadmap, and master plan.
• Lead Data Integrity compliance activities, maturity programmes, remediation initiatives, and continuous improvement.
• Assess new and existing systems, identify remediation opportunities, and support global and local system implementation.
• Lead risk assessments, define mitigation strategies, and coordinate cross-functional projects, dependencies, and priorities.
• Partner with Quality Control and other functions on investigations, deviations, CAPAs, quality metrics, and regulatory requirements.
• Lead Audit Trail Review strategy and governance, author and maintain SOPs, deliver training, and coach employees on Data Integrity principles.

Requirements

• Bachelor’s degree in Science, Engineering, Information Technology, or a related discipline.
• 9+ years of experience in pharmaceutical, biotechnology, or another highly regulated manufacturing environment.
• 5+ years of experience leading projects or programmes.
• 3+ years of experience leading Data Integrity remediation initiatives.
• Strong understanding of EU GMP Annex 11 and 21 CFR Part 11.
• Experience in Quality, Manufacturing, QC Laboratories, or Information Technology functions.

Culture & Benefits

• Permanent or contract engagement options.
• Hybrid work arrangement.
• Opportunity to act as a site Data Integrity Champion and promote a culture of compliance and operational excellence.