Head of Global GxP Quality Management System

Company Description

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team:

• Competitive compensation for your work
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Opportunities for professional growth
• Diversity and Inclusion
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

Job Description

The Head of GxP Quality Management System (QMS) is accountable for the development and implementation of an enterprise-wide QMS strategy covering end-to-end regulated processes conducted by Sobi functions, Affiliates, service providers and partners. The QMS strategy delivers process integrity via compliant, effective, efficient end-to end procesess via adherence to GCP, GVP, GMP, GDP, GLP, Medical Device and other applicable regulations adding value to Sobi and Sobi's patients.  

Are you a seasoned leader with a passion for quality and excellence in the pharmaceutical industry? Sobi is seeking a dynamic and experienced Head of GxP Quality Management System to spearhead our enterprise-wide QMS strategy. In this role, you will ensure that our regulated processes adhere to the highest standards, benefiting both Sobi and our patients.

We are looking for someone who is a role model for others in terms of Sobi’s values and continuously displays a positive can-do attitude. Finally, your proven experience in a similar position will allow you to be successful in this position.

Key Responsibilities:

• Lead the GxP Quality Management System Team 
• Responsible for the delivery of the Global Sobi Quality Management System (QMS) strategy
• Ensuring that products, processes, systems, and procedures comply with cGxP (GMP, GDP, GVP, and GCP), as well as the Medical Device Regulation (MDR) and other relevant authority requirements through solid regulatory surveillance
• Lead the development, maintenance, and continuous improvement of an adaptive QMS framework to align with company strategy and Global Quality Mission
• Responsible to proactively identify needs for standardization, regulatory compliance direction and areas for improvement in QMS
• Responsible for timely and strategic QMS process intelligence
•  Support digitalization of eQMS systems for a virtual setup. 
• Responsible for the implementation and maintenance of Sobi Risk management process 
  Ensure strategic partnership with business partners such as GxP Process Owners, Function Leaders and SMEs at Global and Local level 
•  Establish, maintain and continuously improve GxP processes and procedures within your area of responsibility, ensuring implementation in accordance with applicable laws and regulations and ensuring efficient and effective execution and oversight.
• Ensure integration of QMS related activities into Sobi QMS related to business integration from e.g M&A

Qualifications

About you

At Sobi, we value Care, Ambition, Urgency, Ownership, and Partnership. We are looking for someone who embodies these values and consistently demonstrates a positive, can-do attitude. The ideal candidate will have strong leadership and communication skills, be proactive and result-oriented, and possess the ability to solve complex problems. Collaboration, empathy, and cultural sensitivity are essential, along with the courage to drive change and inspire your team.

• Minimum 15 years of experience in the pharmaceutical industry within global quality systems, quality, manufacturing, product development, and/or regulatory affairs.
• At least 10 years of leadership experience.
• In-depth knowledge of pharmaceutical and medical device regulations, including GMP, GCP, GVP, and MDR.
• Strong experience in QMS digitalization.
• Proven ability to work with high-impact stakeholders and health authorities.
• Experience with performance management, KPIs, and management reporting cycles.
• International experience and cultural awareness.

Additional Information

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