Senior QA Lead - Tech Transfer & NPI (Sterile Pharma)

Ascend Project Management; South Dublin; On-site; EUR 85,000 - 120,000; Full time

Job summary

Ascend Project Management is partnering with a leading life sciences company in South Dublin to recruit an experienced Quality Assurance Specialist. You will provide QA leadership for technology transfer and New Product Introduction within a sterile pharmaceutical manufacturing environment.

You will support transfers onto new and existing filling lines, ensuring plans, risk assessments, documentation and execution meet cGMP and regulatory requirements.

Qualifications

• 8+ years in Quality Assurance within GMP pharmaceutical manufacturing.
• Experience supporting technology transfer and NPI; process validation and PPQ.
• Experience as QA lead or senior QA representative in cross‑functional teams.
• Strong knowledge of GMP, change control, deviation/CAPA and validation lifecycle.
• Ability to assess quality impact with risk‑based decisions and challenge teams.
• Strong communication and stakeholder management across technical/operational functions.

Responsibilities

• Act as QA lead for technology transfer and NPI projects, overseeing knowledge transfer, planning, and PPQ readiness.
• Review and approve transfer plans, process descriptions, risk assessments, validation protocols/reports, and change controls.
• Provide QA oversight of process validation, PPQ readiness, line qualification, media fills, environmental monitoring and equipment qualification.
• Ensure batch records, EB/recipes/SOPs/training/docs are prepared and controlled for product introduction.
• Lead deviations, CAPAs, change controls and quality risk assessments related to transfers, validation and PPQ.
• Collaborate with Process Development, Engineering, Manufacturing, Validation, QC and Regulatory teams to address quality issues and ensure regulatory readiness.

Skills

QA leadership

GMP knowledge

Technology Transfer

New Product Introduction

Process Validation

PPQ

Change Control

Quality Risk Management

Cross-functional collaboration

Regulatory awareness

Job description

Ascend Project Management is partnering with a leading life sciences company in South Dublin to recruit an experienced Quality Assurance Specialist. You will provide QA leadership for technology transfer and New Product Introduction within a sterile pharmaceutical manufacturing environment.

You will support transfers onto new and existing filling lines, ensuring plans, risk assessments, documentation and execution meet cGMP and regulatory requirements.