Site Lead Auditor, Associate Director – Dundalk
MSD Ireland
Our company is seeking a dedicated and experienced Site Lead Auditor, Associate Director to join our team at the Dundalk facility, reporting to the Site Quality Head.
This facility is committed to formulating and filling vaccine products that improve and transform lives globally.
As a Site Lead Auditor, Associate Director, you will play a crucial role in ensuring our processes conform to policies and comply with c GMPs, Health Agency regulations, and all other applicable governing regulations.
Your Key Responsibilities
Develop and implement the Site Internal Audit Program in alignment with startup activities and schedule.
Launch and manage the Permanent Inspection Readiness Program to ensure we're always prepared.
Lead and perform internal audits, including facility, system, and walkthrough audits, while managing the audit schedule.
Advocate for continuous improvement in our Quality Management Systems, making a substantial impact.
Maintain and communicate quality‑related metrics for the Site Internal Audit & Inspection Readiness programs.
Represent the site's Quality Management System during Health Authority Inspections and Global Audits, showcasing our adherence to standards.
Stay updated on technical, compliance, regulatory, and audit skills to ensure the effectiveness of the audit program.
Communicate audit/inspection results to stakeholders and site leaders, and manage CAPA processes for audits and inspections.
What You Bring to the Team (Required)
Bachelor's degree in Biotechnology, Science, or a relevant discipline.
10+ years of experience in the Biopharma/Pharma Industry, including internal audit/Health Authority Inspection experience.
Strong knowledge of relevant c GMPs, US and European c GMP guidelines, ICH, and other international regulatory requirements.
Excellent communication, decision‑making, people influencing, and project management skills.
Strong problem‑solving and critical‑thinking skills with the ability to identify potential compliance issues.
Self‑starter with a focus on results and a desire for continuous learning and improvement.
Preferred
Proven track record in delivering excellence.
First‑hand experience with multiple Health Authority Inspections and a strong motivation to be an inspiring member of a high‑performing team.
Required Skills
Audit Management, Biopharmaceuticals, c GMP Training, Critical Thinking, Detail‑Oriented, Driving Continuous Improvement, Internal Auditing, International Regulatory Compliance, Leadership, Quality Management System Auditing, Technical Writing.
Preferred Skills
Apply as a current employee or contingent worker.
About Us – EEO Statement
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
Additional Information
Employee Status: Regular
Relocation: –
VISA Sponsorship: –
Flexible Work Arrangements: Not Applicable
Job Posting End Date: 01/12/2026
Requisition ID: R377587
Apply Now
Please contact the Talent Acquisition Advisor assigned to this role if you need any support during the recruitment process.
We invite you to apply today.
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