Lead QA Validation & Compliance Specialist

BioSpace; Ireland (WV); Presencial; USD 54.000 - 88.000; Jornada completa

Descripción de la vacante

Regeneron is seeking a Senior QA Validation Specialist to join our Quality Assurance team in Ireland. You will oversee end-to-end qualification of equipment, ensure inspection readiness, and uphold data integrity across systems.

The role requires a BS/BA in Engineering, Chemistry or Life Science and 5–8+ years in regulated environments or pharma/biotech audits. You will lead validation activities, manage projects, and guide junior staff.

Formación

• BS/BA in Engineering, Chemistry or Life Science; 5–8+ years in validated environments.
• Experience as SME in regulated pharma/biotech audits in internal/external settings.
• Strong knowledge of EU Annex 11 and FDA 21 CFR Part 11.

Responsabilidades

• Supervise end-to-end qualification processes for equipment to ensure fitness for intended use.
• Schedule, execute, review and approve qualification activities and reports.
• Assess change controls and deviations for conformance to regs and specs.
• Investigate issues and recommend improvements and changes.
• Coordinate with departments and contractors to complete validation tasks.
• Lead projects and provide direction to junior staff.

Conocimientos

QA Validation

Regulatory Audits

Data Integrity

Project Management

Cross-functional Collaboration

Educación

BS/BA in STEM

Descripción del empleo

Regeneron is seeking a Senior QA Validation Specialist to join our Quality Assurance team in Ireland. You will oversee end-to-end qualification of equipment, ensure inspection readiness, and uphold data integrity across systems.

The role requires a BS/BA in Engineering, Chemistry or Life Science and 5–8+ years in regulated environments or pharma/biotech audits. You will lead validation activities, manage projects, and guide junior staff.