QC Compliance Specialist

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

Job summary

Sanofi Waterford is seeking a QC Compliance Specialist on a fixed term contract to oversee quality governance for QC processes on-site. You will ensure timely investigation and remediation of QC events, lead CAPA actions, and support regulatory inspections.

The role requires a science degree, GMP/regulatory experience, and strong communication with stakeholders. This position offers a challenging environment within a world-class biopharma campus.

Qualifications

• Degree in science or related discipline.
• Experience in quality control within pharma, including GMP knowledge.
• Experience managing internal audits and regulatory inspections.
• Understanding pharmaceutical regulations (FDA, EMA, ICH).
• Strong verbal and written communication to convey compliance requirements.

Responsibilities

• Represent QC for processes led by QMS at site level.
• Investigate and resolve quality control events and discrepancies in a timely manner.
• Implement remediation actions from findings and CAPAs.
• Support regulatory inspections and audits and drive continuous QC improvements.

Skills

Quality control

Regulatory compliance

GMP knowledge

Audits

Communication

Education

Science degree

Third-level qualification

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
• 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.

Equal Opportunity

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.

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.

Salary and Benefits

The salary range for this position is: €48 000,00 - €64 000. Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. 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 www.sanofi.com or via our movie. We are Sanofi Start 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 driven by a shared purpose: we chase the miracles of science to improve people’s lives. 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. 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.