Position Details

PURPOSE
Provide dedicated Quality Assurance support to site project activities and strategic initiatives within the Sligo manufacturing facility. 
Serve as the Quality representative for assigned project workstreams, ensuring GMP, regulatory, and Phibro quality requirements are incorporated throughout project execution. 
Support qualification, validation, operational readiness, and continuous improvement activities impacting commercial vaccine manufacturing. 
Partner with Manufacturing, QC, Engineering, Validation, Regulatory Affairs, Supply Chain, and project teams to ensure compliant and timely project delivery. 
Ensure quality risks are identified, assessed, and managed throughout the project lifecycle while maintaining inspection readiness and site compliance.

KEY RESPONSIBILITIES
• Serve as the QA representative for assigned site projects and strategic initiatives. 
• Ensure GMP and quality requirements are incorporated into project activities. 
• Participate in project governance, planning, and risk assessments.
• Ensure GMP and quality requirements are incorporated into project activities.
• Participate in project governance, planning, and risk assessments.
• Review and approve qualification and validation protocols and reports. 
• Provide QA oversight for facility, utility, equipment, computerized system, cleaning, and process qualification activities. 
• Support execution and closure of qualification and validation activities
• Support implementation and enhancement of site quality systems. 
• Ensure compliance with GMP, data integrity, and Phibro quality standards. 
• Support Veeva Vault, LIMS, and other quality systems required for project execution and operational readiness.
• Review and approve project-related GMP documentation.
• Ensure quality documentation is complete, compliant, and inspection-ready.
• Support development of SOPs and operational quality procedures.
• Partner with Engineering, TSA, Operations, Regulatory Affairs, and Project Management teams.
• Provide quality guidance for change controls, deviations, investigations, and CAPA activities.
• Support operational readiness and technology transfer initiatives.
• Support facility GMP approval and regulatory inspection readiness activities.
• Participate in audits, inspections, and regulatory responses as required.
• Ensure compliance with applicable GMP, EHS, and company requirements.
• Promote a strong quality culture throughout project execution.

KEY COMPETENCIES
Strong understanding of GMP compliance, quality systems, validation requirements, and manufacturing site quality standards
Knowledge of facility, utility, equipment, computerized system, cleaning, and process qualification activities within a regulated manufacturing environment
Ability to operate effectively in a site project environment with multiple stakeholders, deadlines, workstreams, and competing priorities
Strong documentation review and technical writing skills, including protocols, reports, deviations, CAPAs, SOPs, and project documentation

EDUCATION & EXPERIENCE
Essential
• Third-level qualification in a scientific, engineering, quality, pharmaceutical, biotechnology, or related discipline. 
• Minimum 5 years' experience working in a GMP Quality environment, preferably within a manufacturing site. 
• Experience supporting qualification, validation, manufacturing readiness, technology transfer, or site improvement projects. 
• Working knowledge of GMP regulations, QMS, validation lifecycle, change control, deviations, CAPA & data integrity requirements. 
• Experience working within cross-functional teams in a regulated manufacturing environment.
Desired
• Experience supporting regulatory inspections, audits & health authority interactions.