Process & Quality Specialist

Sanofi; Munster; On-site; EUR 55,000 - 75,000; Full time

Job summary

Sanofi is seeking a QC Business Process Specialist in Waterford, Ireland to drive continuous improvement and compliance across the QC Microbiology lab. You will manage SOPs, deviations, CAPAs, GMP compliance, and digital systems (LIMS), ensuring efficient operations aligned with regulatory requirements.

You will work on developing and maintaining an effective compliance program, delivering training, and supporting audits and inspections.

Qualifications

• Experience ensuring compliance with pharmaceutical regulations.
• Experience in managing internal audits and external regulatory inspections.
• Familiarity with FDA, EMA, ICH guidelines.

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.

Skills

Regulatory compliance

GMP knowledge

Communication skills

Attention to detail

Process improvement

Tools

LIMS

Job description

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.

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.