Hybrid Senior QA Upstream Specialist

Msd Ireland; Dunboyne; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid work

Job summary

Merck & Co., Inc. in Ireland seeks a Quality Assurance Senior Specialist (Upstream) to lead QA oversight of upstream manufacturing and cell banking at a state-of-the-art Dunboyne facility.

The role ensures cGMP compliance and regulatory alignment across master/working cell banks and related processes. You will review change controls, deviations and CAPAs, mentor the QA Operations Upstream team, and collaborate with cross-functional teams to sustain a safe and compliant QA culture.

Qualifications

• Degree or postgraduate qualification in Biochemistry, Biotechnology, Microbiology, or related discipline.
• 7–10 years’ experience in QA, QC, or Tech Ops with upstream oversight.
• Knowledge of Master Cell Bank / Working Cell Bank management and regulatory expectations.
• Experience in QRM, investigations, deviations and problem solving as a QA SME.
• Strong written and verbal communication; ability to work under pressure.

Responsibilities

• Provide QA oversight of Upstream Drug Substance manufacturing and cell banking.
• Review and approve changes, deviations, CAPAs, SOPs and related docs.
• Perform QA operational upstream and cell banking duties and release activities.
• Assess new regulatory guidance and implement updates to QA systems.
• Support risk management activities and regulatory interactions during inspections.
• Mentor QA Operations Upstream team to promote safety and compliance culture.
• Escalate compliance risks to management in a timely manner.

Skills

Audit Readiness

cGMP Regulations

Compliance Activities

Corrective Action Management

Deviation Management

Manufacturing Quality Control

Pharmaceutical Quality Assurance

Product Disposition

Quality Assurance Processes

Quality Management Standards

Regulatory Compliance

Education

Degree in Biochemistry, Biotechnology, Microbiology, or related discipline

Job description

Merck & Co., Inc. in Ireland seeks a Quality Assurance Senior Specialist (Upstream) to lead QA oversight of upstream manufacturing and cell banking at a state-of-the-art Dunboyne facility.

The role ensures cGMP compliance and regulatory alignment across master/working cell banks and related processes. You will review change controls, deviations and CAPAs, mentor the QA Operations Upstream team, and collaborate with cross-functional teams to sustain a safe and compliant QA culture.