Upstream QA Senior Specialist: Cell Banking & GMP Oversight

Merck; Ireland; On-site; EUR 80,000 - 110,000; Full time

Job summary

Merck in Ireland is seeking a Quality Assurance Senior Specialist (Upstream) to provide direct QA oversight of Upstream Drug Substance manufacturing and cell banking within a state-of-the-art facility in Dunboyne, Meath. You will lead QA activities, review CAPAs and change controls, and ensure cGMP compliance across processes.

The role requires a degree in Biochemistry/Biotechnology/Microbiology and 7–10 years in QA/QC or technical operations with upstream/cell banking oversight.

Qualifications

• Degree or postgraduate qualification in Biochemistry, Biotechnology, Microbiology, or related discipline.
• 7-10 years' experience in Quality Assurance, Quality Control or Technical Operations with direct oversight of Upstream processing and/or cell banking.
• Demonstrated knowledge of Master Cell Bank / Working Cell Bank management and Regulatory expectations, aseptic processing and GMP environments.
• Experience in QRM, Investigations, Deviations, and problem solving as a Quality SME.
• Strong written and verbal communication skills with ability to work under pressure.
• Team player with initiative and attention to GMP documentation.
• Experience interacting with regulatory agencies during site inspections.

Responsibilities

• Lead QA activities daily with cross-functional teams to address compliance issues.
• Participate in investigations related to deviations/complaints and ensure timely corrective actions.
• Review and approve Change Controls, Deviations/CAPAs, SOPs and related documentation.
• Perform QA operational Upstream and cell banking duties and related release activities to ensure on-time disposition.
• Evaluate new regulatory guidance and best practices and implement updates to Quality systems.
• Support risk management activities in line with guidance and industry practice.
• Provide QA oversight to qualification/validation, tech transfers, regulatory approvals and commercial/clinical operations.
• Mentor QA Operations Upstream team to foster a safe, compliant Quality & Safety culture and escalate risks when needed.

Skills

QA Leadership

Investigations

Deviations/CAPAs

SOP & Documentation

cGMP Compliance

Regulatory Inspections

Risk Management

Mentoring QA Ops Upstream

Education

Biochemistry / Biotechnology / Microbiology degree

Job description

Merck in Ireland is seeking a Quality Assurance Senior Specialist (Upstream) to provide direct QA oversight of Upstream Drug Substance manufacturing and cell banking within a state-of-the-art facility in Dunboyne, Meath. You will lead QA activities, review CAPAs and change controls, and ensure cGMP compliance across processes.

The role requires a degree in Biochemistry/Biotechnology/Microbiology and 7–10 years in QA/QC or technical operations with upstream/cell banking oversight.