Site Lead Auditor (Associate Director)

About the role

The Site Lead Auditor is a pivotal quality leadership position at MSD's sterile fill‑finish manufacturing facility in Carlow. You will lead internal audit and inspection readiness programmes, fostering a strong compliance culture and ensuring cGMP compliance, patient safety, and reliable medicine supply.

Key responsibilities

• Implement and deliver the site internal audit programme aligned with operational priorities.
• Lead the inspection readiness programme, embedding permanent inspection readiness.
• Provide quality oversight for sterile fill‑finish processes to meet cGMP and regulatory requirements.
• Set compliance direction, promote adherence to policies and guidelines.
• Assess site compliance against emerging regulations and industry trends.
• Maintain metrics, communicate audit outcomes, and manage CAPA effectiveness.
• Represent the Quality Management System during health authority and internal GMP inspections.
• Conduct facility, system, and walkthrough audits and manage the audit schedule.

Required profile

• Bachelor’s degree in Chemistry, Biology, Microbiology, Engineering or related field.
• 10+ years in pharma/biologics, with at least 4 years delivering internal audit and inspection readiness programmes.
• Proven GMP auditing experience and ability to work cross‑functionally.
• Strong organisational skills and sound judgement for issue escalation.

Required skills

• Audit Readiness
• Audit Trails
• Compliance Activities
• Corrective Action Management
• Decision Making
• Good Manufacturing Practices (GMP)
• Manufacturing Audits
• Metrics Development
• Quality Improvement Programs
• Quality Management Systems (QMS)
• Quality Risk Management
• Quality Standards
• Regulatory Compliance
• Regulatory Requirements
• cGMP Compliance
• Quality Leadership