Job DescriptionA fantastic opportunity has arisen for a Senior QA Internal Auditor.The Senior QA Internal Auditor role supports the internal audit program and inspection readiness activities as required, as part of the Quality and Internal audit teams. The role ensures that Quality team objectives are effectively achieved, consistent with our company requirements to ensure compliance, safety and reliable supply to customers,Bring energy, knowledge, innovation to carry out the following:• Responsible for leading and performing internal audits (system, product and walkthrough) at the Ballydine site.• Generate and report metrics / trends for internal audit program adherence to requirements and effectiveness.• Lead the preparation and hosting of Health Authority inspections and Divisional GMP Audits.• Maintain current technical, compliance, regulatory, and audit skill knowledge to ensure audit program effectiveness.• Effectively communicate audit/inspection results to stakeholders and site leaders. Evaluate and approve root cause analysis, CAPA responses, monitor CAPA completion, and verify CAPA effectiveness for audits & inspections for complete remediation.• Generate/Review annual audit schedule and audit/inspection performance reports.• Review and approve Audit Reports, including observation ratings and overall audit outcome• Lead change and process initiatives related to audits, inspections, and CAPA.• Perform routine risk communication for Site (Quality Council), Regional, and Divisional Management.• Lead Permanent Inspection Readiness Program on site.• Provide training to site personnel as required, on GMP compliance issues as appropriate.What skills you will need:In order to excel in this role, you will more than likely have:• Degree or postgraduate qualification in Science, Pharmacy, or a related discipline• Pharmaceutical industry experience within a GMP environment.• Extensive knowledge of US and European cGMP guidelines, ICH and other international regulatory requirements.• Experience in GMP auditing across multiple Quality Management systems.• Experience in preparing for and hosting Regulatory Inspections.• Demonstrated knowledge and practical application of Lean principles / Continuous Improvement methodologies.• Collaborates effectively with colleagues; willingly shares information and supports team objectives. Actively listen and seek to understand differing perspectives from project team members; work together to achieve the common goals of the company• Proven leadership with advanced problem-solving and decision-making skills; adept at managing multiple projects, meetings, time, and priorities• Responsible for ensuring that the culture of Continuous Improvement in the Quality Management Systems is based on a solid foundation of compliance and adhering to regulatory requirements.• Excellent oral and written communication skills; able to explain auditing findings and associated risks and influence decision-making.• Excellent trouble shooting and problem-solving skills as well as influencing, collaboration skills and teamworking ability to work with global and interdisciplinary teams.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. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process. 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.So, if you are ready to:Invent solutions to meet unmet healthcare needs, please apply today.Required Skills: Continuous Improvement Techniques, Continuous Improvement Techniques, Critical Thinking, Customer-Focused, Customer Satisfaction, Detail-Oriented, GMP Compliance, Inspection Readiness, IS Audit, Maintenance Management, Management Process, New Product Introduction Process, Pharmaceutical Regulatory Affairs, Pharmacy, Process Qualification, Quality Assurance (QA), Quality Assurance (QA) Standards, Quality Improvement Programs, Quality Management, Quality Management Systems (QMS), Quality Metrics, Quality Process Development, Quality Standards, Regulatory Compliance, Regulatory Requirements {+ 3 more}Preferred Skills: Current Employees apply HERECurrent Contingent Workers apply HERESearch Firm Representatives Please Read Carefully 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. Employee Status: RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:No Travel RequiredFlexible Work Arrangements:HybridShift:Not IndicatedValid Driving License:NoHazardous Material(s):NoJob Posting End Date:02/14/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R382601