Country Quality Head & Responsible Person - Denmark

Sanofi; København; On-site; DKK 672,000 - 1,008,000; Full time

Job summary

Sanofi in Copenhagen seeks a Country Quality Head & Responsible Person for Denmark to lead quality excellence across commercial operations, ensuring patient safety and regulatory compliance.

You will guide risk-based GDP programs, inspections, and cross-functional collaboration within North Europe Quality, shaping how medicines reach patients while advancing a culture of quality throughout the organization.

Qualifications

• University degree in Pharmacy is required.
• Experience as Responsible Person and knowledge of wholesaler activities including narcotics and customs regulations.
• Fluent in Danish and English.
• Strong leadership and cross-functional collaboration.
• In-depth knowledge of GDP and EU MDR and local Danish regulations.

Responsibilities

• Design, implement, and continuously enhance the Country Quality System for all GxP activities.
• Serve as the Responsible Person under Danish regulations and ensure GDP and regulatory compliance.
• Champion a proactive quality culture across the organization and region.
• Lead regulatory inspections and health authority interactions with global counterparts.
• Develop and execute risk-based GDP self-inspection strategies and audits.

Skills

Leadership

Risk management

Stakeholder management

Communication

Quality management

GxP knowledge

Education

Pharmacy degree

Job description

Location: Denmark Job type: Permanent, Full time Salary range: DKK 672.000 - DKK 1.008.000

About the job:

As Country Quality Head & Responsible Person for Denmark within our Quality North Europe function, you'll serve as the guardian of quality excellence across our commercial operations, working at the intersection of regulatory compliance, operational excellence, and patient safety to ensure life-changing medicines reach patients safely. Ready to get started? You'll join our North Europe Quality team based in Copenhagen, playing a strategic leadership role that shapes how we deliver medicines across Denmark. As the quality conscience of the Danish organization, you'll champion a proactive quality culture, lead regulatory compliance, and collaborate closely with cross-functional teams to uphold the highest standards patients deserve.

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:

• Strategic Quality Leadership Design, implement, and continuously enhance the Country Quality System for all GxP and health-regulated activities, embedding a quality mindset into organizational structures, decision-making processes, and daily operations
• Serve as the Responsible Person under Danish regulations, ensuring full compliance with Good Distribution Practice (GDP), EU Medical Device Regulation, and local regulatory requirements
• Champion a proactive quality culture throughout the organization, shaping how life-changing medicines are delivered across the North Europe region
• Regulatory Excellence & Compliance Lead regulatory inspections and health authority interactions, coordinating with global functions to ensure seamless compliance and exceptional outcomes
• Develop and execute risk-based GDP self-inspection strategies, managing the annual audit program and driving continuous improvement based on findings and trends
• Monitor and implement changes from global quality standards and local regulations, ensuring the Country Quality system remains current and robust
• Cross-Functional Collaboration & Influence Serve as the country focal point for Quality Risk Management — both proactive and reactive — ensuring risks are identified, assessed, controlled, and communicated effectively across the organization
• Provide quality expertise and guidance to commercial, medical, regulatory, pharmacovigilance, and supply chain teams, enabling them to operate with quality excellence

About you:

• Experience: Proven track record in pharmaceutical quality management, with experience as a Responsible Person and knowledge of wholesaler activities including distribution of narcotics, and customs regulations
• Soft and technical skills: Strong leadership with ability to influence without direct authority; excellent risk management and problem-solving skills; outstanding communication and stakeholder management abilities; deep knowledge of GDP, EU MDR, and local Danish pharmaceutical regulations; strategic thinking combined with hands-on execution
• Education: University degree in Pharmacy (required)
• Languages: Fluency in Danish and English, both written and spoken (required)

Why choose us?

Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave
• Take on a strategic leadership role with high visibility, directly impacting patient safety across Denmark
• Be part of a collaborative, high-performing North Europe Quality team committed to excellence
• 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.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

More about the position:

The salary range for this position is :kr672 000,00 - kr896 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.

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.