Hybrid Senior Site Lead Auditor – Quality & Compliance

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

Benefits offered by this job

Hybrid work model

Job summary

MSD Ireland in Carlow seeks a Site Lead Auditor to head the internal audit and inspection readiness programmes within a sterile fill-finish manufacturing facility. You will partner with functions to strengthen a compliant culture, ensure cGMP, and support reliable supply of medicines.

Responsibilities include delivering the site internal audit programme, leading inspection readiness, and communicating outcomes to stakeholders while driving CAPA and continuous improvement across the Quality

Qualifications

• Bachelor’s degree or higher in a relevant scientific or engineering discipline.
• Extensive GMP regulatory knowledge and auditing experience.
• Proven ability to lead cross-functional audit programmes.
• Strong analytical and problem-solving skills with stakeholder influence.

Responsibilities

• Lead the site internal audit programme and risk-based oversight.
• Direct the site inspection readiness programme and GMP inspections.
• Provide Quality oversight for cGMP, contamination control, and regulatory compliance.
• Develop and communicate audit metrics, CAPA tracking and effectiveness.
• Engage with stakeholders to sustain a compliant culture and continuous improvement.

Skills

Audit Readiness

Audit Trails

Compliance Activities

Corrective Action Management

Decision Making

GMP

Manufacturing Audits

Metrics Development

Quality Improvement

Quality Management Systems

Quality Risk Management

Quality Standards

Regulatory Compliance

Regulatory Requirements

Education

Bachelor’s degree or higher in Chemistry, Biology, Microbiology, Engineering or another relevant discipline

Job description

MSD Ireland in Carlow seeks a Site Lead Auditor to head the internal audit and inspection readiness programmes within a sterile fill-finish manufacturing facility. You will partner with functions to strengthen a compliant culture, ensure cGMP, and support reliable supply of medicines.

Responsibilities include delivering the site internal audit programme, leading inspection readiness, and communicating outcomes to stakeholders while driving CAPA and continuous improvement across the Quality