Senior QA Specialist (Biotechnology)

Location: Onsite in Raheen, Limerick, Ireland

Company

A biotechnology company developing and commercializing medicines for people with serious diseases.

What you will do

• Lead and support Quality Assurance activities for technology transfer projects.
• Provide QA leadership and oversight for new manufacturing technologies, equipment, computerized systems, and digital solutions.
• Partner with Manufacturing, Engineering, IT, Validation, Supply Chain, and other functions on cross-functional initiatives.
• Facilitate project governance, risk assessments, quality decisions, and monitoring of project risks and performance indicators.
• Support the implementation of MES, electronic batch records, automation platforms, data integration solutions, and advanced manufacturing technologies.
• Develop quality strategies, procedures, training materials, and governance frameworks while identifying opportunities for process simplification and digital innovation.

Requirements

• BS/BA in a scientific discipline or related field with 5+ years of relevant experience, or MS with 4+ years of relevant experience in the pharmaceutical or related industry.
• At least 2 years of specialist experience.
• Experience with technology transfer principles and lifecycle management in a GMP-regulated environment.
• Understanding of computerized system implementation, validation, data integrity, 21 CFR Part 11, Annex 11, and GxP requirements.
• Familiarity with MES, electronic batch records, automation platforms, data historians, analytics tools, and system integrations.
• Ability to manage multiple complex assignments independently and collaborate across technical and business functions.

Culture & Benefits

• Inclusive workplace with equal employment opportunity.
• Comprehensive total rewards package may include bonuses, equity awards, pension or retirement benefits, insurance, paid time off, and family support benefits.
• Roles are generally expected to be performed onsite, with specific expectations confirmed during the recruitment process.
• Reasonable accommodation is available during recruitment for applicants with disabilities or chronic illnesses.