Senior QA Lead – Upstream Biologics (Hybrid)

MSD; Dunboyne; Hybride; EUR 90 000 - 120 000; Plein temps

Résumé du poste

MSD in Ireland seeks a Quality Assurance Senior Specialist (Upstream) to lead QA oversight of Upstream Drug Substance manufacturing and cell banking activities in a state-of-the-art facility. The role includes cross-functional collaboration, cGMP compliance, and regulatory alignment.

The successful candidate will have 7–10 years in QA/QC/Technical Operations within biologics/pharma, with direct oversight of Upstream processes and cell banking, and strong communication skills to mentor the QA

Qualifications

• 7–10 years’ experience in Quality Assurance, Quality Control or Technical Operations in Biologics/pharmaceutical industry.
• Demonstrated knowledge of Master Cell Bank / Working Cell Bank management and regulatory expectations.

Responsabilités

• Provide QA oversight of Upstream Drug Substance manufacturing processes and cell banking activities.
• Lead investigations related to deviations/complaints and ensure timely actions.
• Review and approve Change Controls, Deviations/CAPAs, SOPs and related documents for cGMP compliance.
• Perform QA operational Upstream and cell banking duties and related release activities.

Connaissances

QA leadership

Investigations

Regulatory knowledge

Communication

Formation

Biochemistry/Biotechnology/Microbiology degree

Description du poste

MSD in Ireland seeks a Quality Assurance Senior Specialist (Upstream) to lead QA oversight of Upstream Drug Substance manufacturing and cell banking activities in a state-of-the-art facility. The role includes cross-functional collaboration, cGMP compliance, and regulatory alignment.

The successful candidate will have 7–10 years in QA/QC/Technical Operations within biologics/pharma, with direct oversight of Upstream processes and cell banking, and strong communication skills to mentor the QA