QC Business Process Specialist

Sanofi; Waterford; Hybrid; EUR 48,000 - 64,000; Full time

Benefits offered by this job

Healthcare benefits

Parental leave

Job summary

Sanofi is seeking a QC Business Process Specialist in Waterford, Ireland, to strengthen the QC Microbiology lab by driving SOP/procedure management, deviation and CAPA handling, and GMP compliance. You will support LIMS and digital systems to ensure efficient, compliant operations aligned with regulatory requirements.

The role emphasizes training, documentation, and cross-functional collaboration across global quality and regulatory teams, with a focus on maintaining robust, audit-ready

Qualifications

• Experience ensuring compliance with local, national and international pharmaceutical regulations and standards.
• Experience managing internal audits and external regulatory inspections, including prep, execution and follow-up.
• In-depth understanding of pharmaceutical regulations, guidelines and standards (FDA, EMA, ICH).

Responsibilities

• Contributing to an effective compliance program.
• Ensuring operations comply with regulatory requirements and international standards.
• Providing training and guidance on compliance topics to employees.
• Maintaining compliance documentation for accuracy and completeness.
• Identifying potential compliance risks and helping develop mitigation strategies.
• Supporting investigation and reporting of compliance incidents.
• Managing CAPA to address incidents and prevent recurrence.

Skills

Regulatory compliance

Audit management

Quality systems

GxP knowledge

Tools

LIMS

Job description

Job title: QC Business Process Specialist Location: Waterford , Ireland

About the job: As QC Business Process Specialist within our QC Lab Team, you'll support the QC Microbiology team by driving continuous improvement, standardization, and compliance of laboratory business processes. Ready to get started? This role focuses on SOP/procedure management, deviation and CAPA handling, GMP compliance, and LIMS/digital systems support, ensuring the Microbiology lab operates efficiently, consistently, and in full alignment with regulatory requirements.

About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main responsibilities:

• Contributing to the development and maintenance of an effective compliance program
• Ensuring all operations comply with relevant regulatory requirements and other international standards
• Providing training and guidance to employees on compliance-related topics
• Maintaining compliance-related documentation, ensuring accuracy and completeness
• Identifying potential compliance risks and contributing to the development of strategies to mitigate them
• Supporting the investigation and reporting of compliance incidents
• Managing CAPA to address compliance incidents and preventing recurrence

About you Experience:

• Experience in ensuring compliance with local, national, and international pharmaceutical regulations and standards
• Experience in managing internal audits and external regulatory inspections, including preparation, execution, and follow-up
• In-depth understanding of pharmaceutical regulations, guidelines, and standards (e.g., FDA, EMA, ICH)

Soft and technical skills:

• Strong verbal and written communication skills to effectively convey compliance requirements and updates to various stakeholders
• Keen attention to detail to ensure accuracy in compliance documentation, audits, and reports
• Ability to analyze complex compliance issues, identify root causes, and develop effective solutions
• Proficiency in managing multiple compliance projects simultaneously, ensuring timely completion and adherence to standards

Why choose us? Be part of a pioneering biopharma company where patient insights shape drug development. Work at the forefront of AI-powered science that accelerates discovery and improves outcomes. Collaborate beyond your expertise, sparking new ideas with diverse, multidisciplinary teams. Explore bold career paths – with opportunities to grow through scientific, leadership, and cross-functional moves. Care for yourself and your loved ones with generous health and well-being benefits, including top-tier healthcare and 14 weeks' gender-neutral parental leave. #LI-EUR #LI-Onsite Pursue Progress. Discover Extraordinary. Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what's never-been-done-before. You'll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let's Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

Diversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden.

The salary range for this position is :€48.000,00 - €64.000

Die endgültige Vergütung wird auf Grundlage nachgewiesener Erfahrung, Fähigkeiten, Standort und weiterer relevanter Faktoren bestimmt. Mitarbeitende können berechtigt sein, an den Mitarbeitenden Leistungsprogrammen des Unternehmens teilzunehmen.

Wir sind ein forschendes Biopharma-Unternehmen, das KI anwendet und sich dafür einsetzt, das Leben der Menschen zu verbessern und verantwortungsvoll zu wachsen. Unser Team wird von einem Ziel geleitet: Wir erforschen die Wunder der Wissenschaft, um das Leben der Menschen zu verbessern. Wir möchten eine gesündere, widerstandsfähigere Welt schaffen und das Unmögliche möglich machen, indem wir Medikamente und Impfstoffe für Millionen von Menschen weltweit entdecken, entwickeln und bereitstellen.

Erfahren Sie mehr über uns auf www.sanofi.com oder schauen Sie sich unseren Film an: We are Sanofi Starte eine Karriere, die einen Unterschied macht. Neuerfindung liegt in unserer DNA. Sie hat unsere Entwicklung von einem kleinen französischen Unternehmen zu einem der weltweit führenden Biopharma-Unternehmen vorangetrieben. Ob es darum geht, KI zu nutzen, um die Zeiten der Arzneimittelforschung zu verkürzen, oder Vertrauen im Gesundheitswesen aufzubauen – du kannst unseren Teams dabei helfen, das Leben für Patient*innen, Partner*innen und Gemeinschaften zu verbessern. Hier entwickelst du deine Karriere weiter. Wir öffnen dir die Tür, um neue Möglichkeiten zu entdecken, deine Grenzen zu erweitern und dich mit Menschen zu vernetzen, die von einem gemeinsamen Ziel angetrieben werden: Wir erforschen die Wunder der Wissenschaft, um das Leben der Menschen zu verbessern.