QC Business Process Specialist

Sanofi; Munster; On-site; EUR 60,000 - 90,000; Full time

Job summary

Sanofi Waterford, Ireland, is seeking a QC Business Process Specialist to enhance the QC Microbiology workflow by driving regulatory-compliant processes, SOP management, and CAPA handling. This role focuses on GMP-aligned procedures and LIMS/digital systems support to ensure efficient, compliant lab operations.

The position emphasizes SOP/procedure governance, deviation handling, and continuous improvement within a global biopharma environment, offering opportunities to contribute to a robust

Qualifications

• Experience in ensuring compliance with pharmaceutical regulations and standards.
• Experience in managing internal audits and external regulatory inspections.
• Strong communication skills to convey compliance requirements to stakeholders.

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 strategies to mitigate them
• Supporting the investigation and reporting of compliance incidents
• Managing CAPA to address compliance incidents and prevent recurrence

Skills

Regulatory compliance

Audit experience

Stakeholder communication

Analytical thinking

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.

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.

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.