Manufacturing and Supply
Wo Wunder
der Wissenschaft
für Patient*innen
Realität werden

Job Title: Quality Business Partner

Location: Dublin, Ireland

About This Job

As Country Business Partner and Deputy RP within our Ireland Country Organisation and UKIE MCO Quality team, you'll play a pivotal role in maintaining our quality management system, ensuring regulatory compliance, and supporting strategic business operations across Ireland. You'll manage product quality reviews, technical complaints, and Good Distribution Practice (GDP) responsibilities while serving as a key liaison between manufacturing sites, third-party suppliers, and our business units. This role offers the opportunity to provide expert guidance on GMP and GDP regulations, lead inspection readiness initiatives, and step into the Responsible Person role when required. Ready to get started?

Main Responsibilities

• Ensure product quality and safety — Manage technical complaints, evaluate manufacturing quality reviews, and handle product recalls or quality issues to protect patient safety

• Maintain regulatory compliance — Keep our operations aligned with Irish and EU pharmaceutical regulations, ensuring we meet all licensing requirements and industry standards

• Support business strategy — Provide expert guidance to teams on product development, launch plans, and discontinuation decisions from a quality and regulatory perspective

• Manage supplier relationships — Oversee quality agreements with manufacturing sites and distribution partners, conduct supplier assessments, and ensure they meet our standards

• Lead quality improvement initiatives — Perform risk assessments, investigate root causes of issues, and implement corrective actions to continuously improve our processes

• Prepare for inspections — Maintain audit readiness through self-inspections, document reviews, and ensuring all team members are properly trained on current procedures

• Oversee distribution operations — Monitor temperature controls during storage and transport, manage batch releases for vaccine products, and ensure proper handling of returned or expired products

About You

• You have solid experience in quality assurance, pharmacovigilance, or regulatory affairs, ideally in a pharmaceutical or healthcare setting, with a good understanding of GMP and GDP regulations

• You're skilled at investigating issues, identifying root causes, and implementing practical solutions under pressure while staying organized and flexible when priorities shift

• You work well with diverse teams across manufacturing, distribution, and business units; you can explain complex regulatory concepts clearly and build effective working relationships with internal and external partners

• You have a genuine commitment to quality and safety, with the ability to manage documentation, data integrity, and audit readiness with precision

• You take initiative, manage your own workload effectively, and aren't afraid to escalate concerns or seek guidance when needed

• You hold a diploma or equivalent qualification in quality assurance, or you've completed recognized internal quality training that demonstrates your expertise

• You communicate confidently in English, both written and verbal, as this is essential for regulatory interactions and cross-functional collaboration

We are proud to be a Disability Confident Employer, committed to offering interviews to candidates who request consideration under the Scheme and meet the minimum requirements for this role.

If you have a disability and require adjustments for the interview process, please email us at diversity.recruitmentUKIE@sanofi.com. We are dedicated to ensuring an inclusive and supportive experience for all applicants.

Visas for those who do not already have the right to work in the UK will be considered on a case by case basis according to business needs and resources.

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