About the job

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.
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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.