Senior QA SME — GMP & PQS Leader

APC; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

VLE Therapeutics is seeking an experienced Senior QA Specialist to provide expert QA oversight across its Pharmaceutical Quality System (PQS). The role will act as a SME for deviations, CAPA, change control, QRM, validation and supplier quality, aligning with GMP and regulatory requirements.

Working with the Senior Quality Manager, QP, and QA team, you will support manufacturing, QC, supply chain and GxP operations while driving continuous improvement and inspection readiness.

Qualifications

• Minimum 5 years of QA experience in a GxP-regulated biopharma or pharmaceutical environment.
• Demonstrated expertise in PQS elements including deviations, CAPA, change control, and QRM.
• In-depth knowledge of GMP regulations (FDA, EMA, ICH).
• Experience with external service provider oversight, quality agreements, and supplier quality management.
• Experience in QMS validation and qualification desirable.
• Strong interpersonal, communication, and project management skills; cross-functional influence.
• Experience supporting regulatory inspections and delivering inspection readiness initiatives.

Responsibilities

• Serve as QA SME for PQS elements across deviations, change control, complaints, validation and QRM.
• Manage and execute operational QA activities to ensure timely, compliant records.
• Oversee review and approval of SOPs and controlled documents; author QA procedures.
• Develop, monitor and report quality metrics to drive timely QA actions.
• Partner with Senior Quality Manager, QP and QA team to achieve PQS objectives.
• Provide QA oversight for Master Batch Records and batch documentation.
• Lead QRM activities in alignment with ICH Q9 and risk mitigation.
• Support development and expansion of QA service capabilities.

Skills

QA oversight

GxP knowledge

QRM

CAPA

Deviation management

Change control

Supplier quality

Regulatory inspections

Education

Bachelor’s degree in life sciences/chemistry/engineering

Job description

VLE Therapeutics is seeking an experienced Senior QA Specialist to provide expert QA oversight across its Pharmaceutical Quality System (PQS). The role will act as a SME for deviations, CAPA, change control, QRM, validation and supplier quality, aligning with GMP and regulatory requirements.

Working with the Senior Quality Manager, QP, and QA team, you will support manufacturing, QC, supply chain and GxP operations while driving continuous improvement and inspection readiness.