Site Lead Auditor (Associate Director)

MSD Malaysia; Carlow; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

MSD is seeking a Site Lead Auditor at the Carlow sterile fill-finish facility to lead the site internal audit and inspection readiness programmes, ensuring cGMP compliance and patient safety. You will partner across the quality organisation to build a strong, sustainable compliance culture.

The role focuses on risk-based oversight, regulatory intelligence, timely CAPA closure and clear communication of audit outcomes to site leadership, supporting readiness for Health Authority inspections and

Qualifications

• Bachelor’s degree or higher in Chemistry, Biology, Microbiology, Engineering or a relevant discipline.
• 10+ years of experience in the pharmaceutical or biologics industry with at least 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 elevate issues for resolution.

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 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.

Skills

Audit Readiness

Audit Trails

Compliance Activities

Corrective Action Management

Decision Making

GMP

Manufacturing Audits

Metrics Development

Quality Improvement

QMS

Quality Risk Management

Quality Standards

Regulatory Compliance

Regulatory Requirements

cGMP Compliance

Education

Bachelor’s degree or higher in Chemistry, Biology, Microbiology, Engineering or related discipline

Job description

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 elevate 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.

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

Employment Details

• 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

The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.