Head of Quality Audits & Inspections

Are you an experienced leader with a strategic mindset and a passion for turning compliance requirements into business value If you excel in leading teams and ensuring compliance across a global organization you may be our next Head of Quality Audits & Inspections

About the job

As Head of Quality Audits & Inspections you will lead and develop Orifarms Corporate Audit & Inspection team to ensure adherence with regulatory requirements internal quality standards and company procedures. You will be responsible for providing strategic quality and compliance guidance across the organization.

Your key responsibilities include:

• Leading the team by providing coaching and performance management
• Developing and executing the annual risk-based audit program covering GxP processes affiliates manufacturing sites suppliers and service providers
• Ensuring compliance with global regulations quality standards and company procedures
• Continuously improving Orifarms audit and inspection management processes
• Driving inspection readiness activities
• Supporting regulatory authority inspections and customer audits
• Reviewing audit reports and ensuring timely closure of observations through effective CAPA management
• Monitoring audit and inspection trends and identifying systemic issues
• Developing compliance KPIs to support management decision-making

Who are you

You have leadership experience and several years of experience within Quality Assurance GxP Compliance Auditing Inspection Management or related functions. You preferably have a certified Lead Auditor qualification as well as extensive knowledge of global regulatory requirements (GMP GDP ICH FDA etc.).

We are looking for someone with strong leadership and people management skills based on high integrity and professional credibility. You have strong analytical and problem-solving capabilities combining strategic thinking with a risk-based approach. You are also results-oriented and are always looking to make improvements. Maintaining positive stakeholder relationships is a priority for you and you are collaborative and capable of leading cross-functional initiatives.

Who are we

You will become part of Corporate Quality a team of 14 dedicated Quality Lead Auditors. Together we work together in ensuring quality and compliance at Orifarm. We offer an international and collaborative environment with a strong emphasis on knowledge sharing and continuous improvement.

Why should you join Orifarm

At Orifarm we are united by a shared purpose: improving access to affordable medicine for the people who need it. Founded in Odense in 1994 by Birgitte & Hans Bøgh-Sørensen we have built our business on challenging conventional thinking to make affordable high-quality pharmaceuticals more accessible across Europe. Rather than developing new medicines we focus on finding smarter ways to bring existing treatments to patients creating value for pharmacies healthcare systems and society.

We live by the mindset Challenge Accepted. It reflects our explorer spirit and can-do attitude where challenges are perceived as opportunities. We encourage people to ask questions challenge assumptions and take ownership. Across teams functions and markets you will find a collaborative and supportive culture built on trust respect and a flat hierarchy where everyone has a voice and direct access to decision-makers.

When you join Orifarm you will be empowered to make a real impact from day one. We offer autonomy and great opportunities for career advancement enabling our employees to shape their professional development. We value flexibility and provide a hybrid work model with the possibility of working from home two days a week.

We invite you to join Orifarm if you are curious ambitious and accept the challenge of bringing better deals of medicine to millions.

We encourage everyone to apply

AtOrifarm we welcome people from all backgrounds recognizing that the best outcomes come from a diverse and inclusive work environment. Our commitment is to create an environment where different perspectives and skills drive innovation and contribute to a sustainable future. By creating such an environment we are confident that we can achieve better results together.

Job location

Odense Denmark. Part of the department is in Warsaw and participation in audits is required occasionally.