Job Description
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 cGMPs, Health Agency regulations, and all other applicable governing regulations. If you are passionate about quality assurance and continuous improvement, we invite you to apply for this exciting opportunity.
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 are 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.
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
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 cGMPs, US and European cGMP 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.
Experience with multiple Health Authority Inspections and motivation to be an inspiring member of a high‑performing team.
Required Skills
Audit Management, Biopharmaceuticals, cGMP Training, Critical Thinking, Detail‑Oriented, Driving Continuous Improvement, Internal Auditing, International Regulatory Compliance, Leadership, Quality Management System Auditing, Technical Writing
Preferred Skills
Current Employees apply HERE. Current Contingent Workers apply HERE.
Secondary Language(s)
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.
Equal Opportunity Statement
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
Contact
Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
Flexible Work Arrangements
We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office‑based colleagues around the world. Please feel free to speak to us about what flexibility means to you during your application.
Recruiting Note
So, if you are ready to invent solutions to meet unmet healthcare needs, please apply today.
Recruiter Note
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre‑existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Other Details
Employee Status: Regular
Relocation: Not Specified
VISA Sponsorship: Not Specified
Travel Requirements: Not Specified
Flexible Work Arrangements: Not Applicable
Shift: Not Specified
Valid Driving License: Not Specified
Hazardous Material(s): Not Specified
Job Posting End Date: 01/12/2026 (A job posting is effective until 11:59:59 PM on the day BEFORE the listed job posting end date.)
Requisition ID: R377587
Recruitment Information
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