Senior Manager QA Auditor

Cpl; Dublin; Hybrid; EUR 120,000 - 180,000; Full time

Benefits offered by this job

RSUs

Job summary

CPL in Ireland seeks a Senior Manager, Quality Assurance – Auditing to lead risk-based audits of internal processes, CMOs, laboratories, and distributors, and drive CAPAs to closure within a GMP/GDP framework. You will support regulatory authority inspections and maintain inspection readiness, while contributing to the broader QMS through deviations, CAPAs, change controls, and SOP reviews.

Expect approximately 50% travel across Europe in a fast-paced, matrixed environment requiring strong

Qualifications

• 8+ years of QA experience within pharma is required.
• Extensive internal and external auditing experience is essential.
• Experience auditing European CMO sites and familiarity with GMP, GLP, GCP, and/or GVP is a plus.

Responsibilities

• Audit internal processes, CMOs, laboratories, distributors, and other vendors.
• Communicate findings to stakeholders and drive CAPAs to closure.
• Support regulatory authority inspections and lead backroom activities for inspection readiness.
• Contribute to the QMS through review/approval of deviations, CAPAs, change controls, and SOPs.

Skills

Auditing

Stakeholder communication

Regulatory inspections

GMP knowledge

Audit leadership

Risk management

Education

Bachelor's degree in a scientific discipline

Job description

Senior Manager, Quality Assurance – Auditing

A global commercial biopharmaceutical company dedicated to rare disease treatments is seeking a Senior Manager, Quality Assurance – Auditing to join the Quality team. This role focuses on GMP and GDP compliance across commercial and clinical operations, spanning both small and large molecule programs. Join an organisation who are passionate about improving patient outcomes.

Extensive Experience In Internal And External Auditing Essential.

Remote/hybrid working in Ireland with 50% European Travel

Role

You'll lead and execute risk-based audits of internal processes, CMOs, laboratories, distributors, and other vendors, communicating findings to stakeholders and driving CAPAs through to closure. You'll also play a key role during regulatory authority inspections, leading backroom activities and supporting inspection readiness, while contributing to the broader QMS through review and approval of deviations, CAPAs, change controls, and SOPs.

Requirements

• Bachelor's degree in a scientific discipline and at least 8 years' relevant experience in Quality Assurance within Pharma
• Extensive experience in internal and external auditing
• Experience in conducting audits in European CMO sites
• Detailed GMP knowledge, proven audit leadership experience, and a track record of building strong working relationships across internal teams and external vendors. Experience supporting regulatory agency inspections is essential, and familiarity with GCP, GLP, and/or GVP is a plus.

• Competitive salary and comprehensive benefits package including RSUs.

This is a fast-paced, matrixed environment requiring strong planning and communication skills, and the role involves approximately 50% travel.