Senior Site Lead Auditor & Compliance Champion

MSD; Carlow; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

MSD is seeking a Site Lead Auditor at the Carlow sterile fill-finish facility to lead the site internal audit and inspection readiness programmes, ensuring cGMP compliance and patient safety. You will partner across the quality organisation to build a strong, sustainable compliance culture.

The role focuses on risk-based oversight, regulatory intelligence, timely CAPA closure and clear communication of audit outcomes to site leadership, supporting readiness for Health Authority inspections and

Qualifications

• Bachelor’s degree or higher in Chemistry, Biology, Microbiology, Engineering or a relevant discipline.
• 10+ years of experience in the pharmaceutical or biologics industry with at least 4 years delivering site internal audit and inspection readiness programmes in a regulated environment.
• Demonstrated GMP auditing experience within the pharmaceutical industry.
• Proven ability to work cross-functionally, deliver against schedules and thrive in an interdependent work culture.
• Strong organisational skills, with the ability to manage multiple priorities and exercise sound judgement on when to elevate issues for resolution.

Responsibilities

• Implementation and ongoing delivery of the site internal audit programme, aligned with site operational priorities.
• Lead the site inspection readiness programme, embedding a culture of permanent inspection readiness.
• Provide Quality oversight to ensure sterile fill-finish manufacturing processes comply with cGMP, contamination control expectations and regulatory requirements.
• Set clear compliance direction for the site by promoting adherence to divisional policies, guidelines and regulatory requirements.
• Lead proactive assessment of site compliance against emerging regulations, industry expectations and regulatory trends.
• Establish and maintain meaningful metrics for the site internal audit programme, ensuring timely communication, action tracking and follow-up.
• Represent the site Quality Management System during Health Authority and internal GMP inspections.
• Lead and perform facility, system and walkthrough audits, and manage the site internal audit schedule.
• Maintain current technical, compliance, regulatory and auditing expertise to strengthen programme effectiveness and identify early compliance warning signals.
• Communicate audit and inspection outcomes clearly to stakeholders and site leaders; critically assess root cause analyses and CAPA responses; monitor completion; and verify effectiveness to support sustainable remediation.
• Support the preparation for and hosting of Health Authority inspections and divisional GMP audits.
• Generate, analyse and report programme metrics and trends to demonstrate adherence, identify risk and drive ongoing effectiveness.

Skills

Audit Readiness

Audit Trails

Compliance Activities

Corrective Action Management

Decision Making

GMP

Manufacturing Audits

Metrics Development

Quality Improvement

QMS

Quality Risk Management

Quality Standards

Regulatory Compliance

Regulatory Requirements

cGMP Compliance

Education

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

Job description

MSD is seeking a Site Lead Auditor at the Carlow sterile fill-finish facility to lead the site internal audit and inspection readiness programmes, ensuring cGMP compliance and patient safety. You will partner across the quality organisation to build a strong, sustainable compliance culture.

The role focuses on risk-based oversight, regulatory intelligence, timely CAPA closure and clear communication of audit outcomes to site leadership, supporting readiness for Health Authority inspections and