QC Compliance Specialist

Sanofi Group; Munster; On-site; EUR 48,000 - 64,000; Full time

Benefits offered by this job

Onsite gym

Medical centre

Job summary

Sanofi Waterford is seeking a QC Compliance Specialist to represent QC for site-level processes and lead timely investigations of quality control events. You will drive CAPAs, track changes, and maintain robust QC documentation in line with the site QMS.

The role supports regulatory inspections, promotes continuous improvement, and ensures cGMP compliance, with a focus on quality and patient safety at our Waterford campus.

Qualifications

• Third Level qualification (degree in science or related discipline preferred).
• Experience in quality control within the pharmaceutical industry, including GMP/regulatory requirements.
• Experience in managing internal audits and external regulatory inspections, including preparation, execution, and follow‑up.
• In‑depth understanding of pharmaceutical regulations, guidelines, and standards (FDA, EMA, ICH).
• Ability to analyze complex compliance issues, identify root causes, and develop effective solutions.
• Proficiency in identifying issues and implementing effective solutions to resolve quality control problems.
• Strong verbal and written communication skills to effectively convey compliance requirements and updates to stakeholders.

Responsibilities

• Representing QC for site-level processes led by QMS team.
• Investigating quality control events and discrepancies; implementing CAPAs.
• Managing follow-up and progress tracking of events, change control and CAPAs.
• Contributing to develop, implement, and maintain an effective QC compliance program.
• Issuing and approving local quality control documentation aligned with the site QMS.
• Supporting regulatory inspections and audits.
• Leading continuous improvement initiatives in QC with the QC excellence team.
• Ensuring compliance to cGMP at all times.

Skills

Quality compliance

Regulatory understanding

Audits

Communication skills

Education

Degree in science

Job description

Job title

QC Compliance Specialist

Location

Waterford, Ireland

Job type

Fixed Term Contract/12months

Working arrangements

On-site, days role

About the job

At Sanofi, we’re committed to providing the next‑gen healthcare that patients and customers need. For more than 20 years, our Waterford team has continued to grow and diversify to serve patients around the world. Today, a team of almost 800 works together at a state‑of‑the‑art biopharmaceutical and medical device campus. Recognized through multiple local and national awards, Sanofi Waterford offers flexible working and access to a world of opportunities to grow your career at one location. As well as attractive benefits, the team enjoy access to an onsite gym and medical Centre that underpin a strong commitment to health and wellbeing.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible.

Key responsibilities

• Representing QC for the processes led by QMS team at site level
• Investigating in a timely manner and resolving any quality control events, issues, or discrepancies from his/her perimeter. Implementing remediation actions from findings and CAPAs
• Managing the consolidated follow‑up and progress tracking of events (eg deviation, lab investigations), change control and CAPAs, related to QC, coordinating with respective QC areas and other involved functions, to ensure they are managed and closed as committed
• Contributing to develop, implement, and maintain an effective compliance program for QC
• Ensuring issuance and approval of appropriate local quality control documentation, when required to support the QMS processes applicable to QC, in alignment with the site QMS
• Investigating on a timely manner and resolving any quality control events, issues or discrepancies from his/her perimeter. Implementing remediation actions from findings and CAPAs
• Providing support during regulatory inspections and audits
• Leading initiatives for continuous improvement in QC, in coordination with QC excellence team
• Ensure compliance to Good Manufacturing Practices (cGMP) at all times

About you

To excel in this role you will need to have:

• Third Level qualification (degree in science or related discipline preferred)
• Experience in quality control within the pharmaceutical industry, including knowledge of Good Manufacturing Practices (GMP) and regulatory requirements
• 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)
• Ability to analyze complex compliance issues, identify root causes, and develop effective solutions
• Proficiency in identifying issues and implementing effective solutions to resolve quality control problems
• Strong verbal and written communication skills to effectively convey compliance requirements and updates to various stakeholders

Equal opportunity

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

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.

Salary

The salary range for this position is :48 000,00 - 64 000

Benefits

Employees may be eligible to participate in Company employee benefit programs.

Company overview

We are an R&D driven, AI‑powered biopharma company committed to improving people’s lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives.

We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world.

Discover more about us visiting or via our movie We are Sanofi ( a career that makes a difference.

Reinvention is in our DNA. It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug‑discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities.

This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.

Motivation

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.

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

Slogan

Pursue progress, discover extraordinary.