Site Lead Auditor – Associate Director (Hybrid)

MSD Malaysia; Carlow; Hybrid; EUR 130,000 - 185,000; Full time

Job summary

Merck & Co., Inc. seeks a Site Lead Auditor (Associate Director) in Carlow, Ireland to lead internal audits, inspection readiness, and quality oversight for sterile fill-finish manufacturing.

You will drive cGMP compliance, regulatory readiness, and continuous improvement while partnering with cross-functional teams. The role requires a strong track record in GMP auditing, leadership, and strategic execution to strengthen the site’s compliance culture and readiness for Health Authority

Qualifications

• Bachelor’s degree or higher in a relevant discipline.
• 10+ years of experience in the pharmaceutical/biologics industry with at least 4 years delivering site internal audit and inspection readiness programmes.
• Demonstrated GMP auditing experience within the pharmaceutical industry.
• Proven ability to work cross-functionally and manage multiple priorities.
• Strong organisational skills with sound judgement on escalation.

Responsibilities

• Lead the site internal audit programme aligned with site priorities.
• Head the site inspection readiness programme and foster a culture of permanent readiness.
• Provide Quality oversight to ensure cGMP and regulatory requirements are met.
• Promote adherence to divisional policies and regulatory guidelines.
• Lead assessment of site compliance against emerging regulations and trends.
• Establish metrics for the audit programme and communicate findings to stakeholders.

Skills

Audit Readiness

GMP Compliance

Quality Management Systems

Regulatory Compliance

Cross-functional Leadership

Education

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

Job description

Merck & Co., Inc. seeks a Site Lead Auditor (Associate Director) in Carlow, Ireland to lead internal audits, inspection readiness, and quality oversight for sterile fill-finish manufacturing.

You will drive cGMP compliance, regulatory readiness, and continuous improvement while partnering with cross-functional teams. The role requires a strong track record in GMP auditing, leadership, and strategic execution to strengthen the site’s compliance culture and readiness for Health Authority