Site Lead Auditor (Associate Director)

Job Description The Site Lead Auditor is a pivotal Quality leadership role within the companys quality organisation at the Carlow site, a sterile fill-finish manufacturing facility. You will lead the site internal audit and inspection readiness programmes, partnering across the organisation to build a strong, sustainable compliance culture. Through risk-based oversight, proactive regulatory intelligence and effective stakeholder engagement, you will help ensure cGMP compliance, patient safety and the reliable supply of medicines to our customers. Key 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 applicable 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. Bring energy, knowledge & innovation to carry out the following: • The motivation and presence to be an inspiring contributor within a high-performing, collaborative team. • Strong communication, decision-making, influencing and project management skills. • Excellent problem-solving and critical-thinking capability, with the ability to connect technical and Quality System information and recognise potential compliance risks. • Knowledge, experience and leadership style to guide planning, strategy development and execution, supporting right-first-time performance and sustained compliance across the site’s sterile fill-finish operations. • A strong record of leadership and team contribution, with the judgement and accountability required for this highly responsible role. • Expert knowledge of cGMP and Quality System regulations relevant to the site. Qualifications and Experience • Bachelor’s degree or higher in Chemistry, Biology, Microbiology, Engineering or another relevant discipline. • 10+ years of experience in the pharmaceutical or biologics industry with a minimum of 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 escalate issues for resolution. Our facility in Carlow site broke ground in 2008 and is a filling site for the launch and commercial supply of vaccines, biologics and small molecule drug product. Since its initial launch, the site has attracted significant internal investment and is now home to a number of state-of-the-art production facilities, laboratories and temperature-controlled warehousing units. The Carlow site is a significant employer in the South East region and attracts high performing talent through close collaborations with universities and colleges in the region 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: 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 Preferred Skills: cGMP Compliance, Quality Leadership Current Employees apply HERE Current Contingent Workers apply HERE Search 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: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 10/20/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the list