Head of Quality Compliance

Sanofi; Waterford; On-site; EUR 84,000 - 112,000; Full time

Job summary

Sanofi Waterford seeks a Head of Quality Compliance to ensure site-wide regulatory adherence, lead a dedicated compliance team, and drive inspection readiness, risk management, and continuous improvement. You will partner with regulators and stakeholders to uphold patient safety and product quality with a data-driven approach.

The role demands strong leadership, extensive regulatory knowledge (FDA/EMA/ICH), and a proven track record in audits and inspections, with a passion for building a

Qualifications

• Significant experience in compliance, quality, or regulatory affairs within the pharmaceutical industry, ideally in a senior leadership role, with experience as a Qualified Person being highly desirable
• Extensive knowledge of local, national, and international pharmaceutical regulations and standards, including FDA, EMA, and ICH guidelines
• Proven track record of managing internal audits and hosting external regulatory inspections, from preparation through to execution and follow-up
• Strong analytical and problem-solving skills, with the ability to assess complex compliance issues, identify root causes, and implement effective, sustainable solutions
• Excellent communication and stakeholder management skills, with the confidence to convey compliance requirements clearly across all levels of the organisation
• Demonstrated ability to lead and inspire a team, with experience in coaching, performance management, and building a culture of quality and compliance
• Highly organised with strong attention to detail, able to manage multiple compliance projects simultaneously and deliver to deadlines

Responsibilities

• Develop, implement, and maintain an effective site compliance programme, ensuring adherence to all applicable pharmaceutical laws, regulations, and standards
• Lead inspection readiness activities and represent the company during regulatory inspections and audits, ensuring timely and effective follow-up on all findings
• Proactively identify, track, and mitigate compliance and quality risks, managing any issues or allegations with appropriate corrective and preventive actions
• Build and maintain strong relationships with regulators, industry associations, customers, and suppliers, representing the company on all compliance-related matters
• Establish and monitor KPIs and compliance metrics, reporting performance to senior management and driving data-led continuous improvement initiatives
• Coordinate quality alerts and batch recall processes in collaboration with global teams, ensuring timely reporting to relevant authorities
• Lead, coach, and develop the compliance team, fostering a high-performance culture and supporting professional growth across the function

Skills

Leadership

Regulatory affairs knowledge

Analytical skills

Communication skills

Job description

Job Title

Head of Quality Compliance

Location

Waterford, Ireland

Job Type

Permanent, Full-time

Working Arrangement

On-site

About the job

As Head of Quality Compliance within our Quality team at Waterford, you'll take ownership of ensuring our site operates in full compliance with pharmaceutical regulations, industry standards, and internal quality requirements. Leading a dedicated compliance team, you'll be the driving force behind our inspection readiness, risk management, and continuous improvement agenda — building strong relationships with regulators and stakeholders while championing a culture of compliance that puts patients at the heart of everything we do.

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

• Develop, implement, and maintain an effective site compliance programme, ensuring adherence to all applicable pharmaceutical laws, regulations, and standards
• Lead inspection readiness activities and represent the company during regulatory inspections and audits, ensuring timely and effective follow-up on all findings
• Proactively identify, track, and mitigate compliance and quality risks, managing any issues or allegations with appropriate corrective and preventive actions
• Build and maintain strong relationships with regulators, industry associations, customers, and suppliers, representing the company on all compliance-related matters
• Establish and monitor KPIs and compliance metrics, reporting performance to senior management and driving data-led continuous improvement initiatives
• Coordinate quality alerts and batch recall processes in collaboration with global teams, ensuring timely reporting to relevant authorities
• Lead, coach, and develop the compliance team, fostering a high-performance culture and supporting professional growth across the function

About you

• Significant experience in compliance, quality, or regulatory affairs within the pharmaceutical industry, ideally in a senior leadership role, with experience as a Qualified Person being highly desirable
• Extensive knowledge of local, national, and international pharmaceutical regulations and standards, including FDA, EMA, and ICH guidelines
• Proven track record of managing internal audits and hosting external regulatory inspections, from preparation through to execution and follow-up
• Strong analytical and problem-solving skills, with the ability to assess complex compliance issues, identify root causes, and implement effective, sustainable solutions
• Excellent communication and stakeholder management skills, with the confidence to convey compliance requirements clearly across all levels of the organisation
• Demonstrated ability to lead and inspire a team, with experience in coaching, performance management, and building a culture of quality and compliance
• Highly organised with strong attention to detail, able to manage multiple compliance projects simultaneously and deliver to deadlines

Why choose us?

Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply. Help deliver 30+ new product launches by 2030, ensuring patients get treatments faster than ever. Develop new skills, explore cross-functional roles, and work in an environment that values growth and discovery. Pursue progress, discover extraordinary 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.

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.

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

The salary range for this position is €84 000,00 - €112 000 Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors.

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 who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.