Head of Global Gxp Compliance

**Company Description**
Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.

Are you a seasoned professional with extensive experience in the pharmaceutical industry and great competence in GxP quality and compliance? Sobi is seeking a dynamic individual to lead our Global GxP Compliance & Quality Systems department within the Global Quality team.

This is an opportunity to lead a global team and contribute to the development of competitive products in a growing company, by engaging in strategic decision-making processes and quality management.

**Key Responsibilities**
- Lead the design and implementation of a proactive Quality organization to ensure compliance and reliable product supply and development.
- Develop and maintain an adaptable Quality management System to meet Sobi´s growth journey in accordance with regulatory guidelines and Sobi global processes
- Responsible for governance and development of GxP/MDR processes
- Drive digitalization and development of eQMS systems for a virtual setup. Responsible for eQMS modules in Veeva
- Management ofaudits within GMP, GDP.
- Monitor regulatory requirements for GxP/MDR.
- Responsible for quality KPI reporting
- Build competencies for due diligence activities.

**Qualifications**
- Minimum 15 years of experience in the pharmaceutical industry, focusing on global Quality systems, manufacturing, product development, and regulatory affairs
- Minimum 10 years of leadership experience in a global environment
- Experience in managing Quality Management Systems within the pharmaceutical industry.
- Strong knowledge of cGxP (GMP, GDP, GVP, GCP) with focus on GMP/GDP, MDR, and regulatory requirements.
- Leadership skills to manage a team and drive efficiency improvements.
- Excellent communication and collaboration abilities with stakeholders.
- Holistic business understanding
- Courageous, empathetic, and trustworthy

**Additional Information**
In addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.

All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.

**Why Join Us?**

We are a global company with over 1,700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

**Sobi Culture**

At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

**An Equal Opportunity Employer