QA Lead - Digitalization & Tech Transfer

Initial Therapeutics, Inc.; Ireland; On-site; EUR 54,200 - 88,400; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension/retirement benefits

Health insurance

Job summary

Regeneron in Raheen, Limerick, Ireland, is seeking a Senior QA Specialist to join the Quality Assurance team. This role focuses on technology transfer, digital quality programs, and partnering with cross‑functional stakeholders to ensure robust quality systems.

You will drive QA leadership for new manufacturing technologies, MES implementations, electronic batch records, and automated systems while ensuring compliance with GMP, 21 CFR Part 11, and Annex 11, contributing to patient‑centered

Qualifications

• BS/BA in scientific discipline or related field with 5+ years or MS 4+ years of relevant work experience in pharmaceutical or related industry or equivalent combination of education and experience.

Responsibilities

• Lead and support QA activities for technology transfer projects, ensuring knowledge transfer, risk management, and quality requirements are met.
• Provide QA project leadership for new manufacturing technologies, equipment, computerized systems, and digital solutions.
• Collaborate with Manufacturing, Engineering, IT, Validation, and Supply Chain to support cross‑functional initiatives across IOPS.
• Facilitate governance, risk assessments, and quality decision‑making for technology implementation and digitalization programs.
• Promote data‑driven and digital quality improvements to enhance processes, visibility, and performance.

Skills

Quality Assurance

Risk management

Cross‑functional collaboration

GMP compliance

Digitalization

Education

BS/BA in scientific discipline

MS degree (4+ years)

Tools

MES

Electronic batch records

Automation platforms

Data historians

Analytics tools

System integrations

Job description

Regeneron in Raheen, Limerick, Ireland, is seeking a Senior QA Specialist to join the Quality Assurance team. This role focuses on technology transfer, digital quality programs, and partnering with cross‑functional stakeholders to ensure robust quality systems.

You will drive QA leadership for new manufacturing technologies, MES implementations, electronic batch records, and automated systems while ensuring compliance with GMP, 21 CFR Part 11, and Annex 11, contributing to patient‑centered