QC Business Process Specialist

Sanofi Inc.; Waterford; On-site; GBP 47,000 - 73,000; Full time

Job summary

Sanofi in Waterford, Ireland, seeks a QC Business Process Specialist to drive continuous improvement, standardization, and regulatory-aligned processes within the QC Lab Team. You will focus on SOP management, deviation handling, CAPA, GMP compliance, and support for LIMS/digital systems to keep the microbiology lab efficient and compliant.

The role requires experience with pharmaceutical regulations (FDA, EMA, ICH), audits, inspections, and strong documentation practices.

Qualifications

• Experience ensuring compliance with pharma regulations (FDA, EMA, ICH)
• Experience in internal audits and regulatory inspections
• Strong understanding of GMP and quality systems

Responsibilities

• Develop and maintain an effective compliance program
• Ensure operations comply with regulatory requirements and standards
• Provide training on compliance topics
• Maintain accurate compliance documentation
• Identify compliance risks and help mitigate them
• Support investigations and reporting of compliance incidents
• Manage CAPA to prevent recurrence

Skills

Regulatory compliance

Audits & inspections

CAPA management

Documentation

Education

Bachelor's degree in Life Sciences or related field

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 programEnsuring 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.

You'll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve.

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.