Head of QA EU & International

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 need lifesaving treatments.

Job Description

You will lead and manage the team QA EU & International reporting to the Head of Global QA External Operations within Global Quality. QA EU & International is accountable for GMP/GDP compliance across Sobi´s external supplier network within EU and International through robust quality oversight including Quality Operations from development to commercial products. QA EU &International is also responsible for ensuring optimal efficacy by embracing operational excellence and fostering a culture of continuous improvement by proactively identify and navigate the opportunities and risks inherent in the lifecycle of Sobi products, maintaining adherence to GMP/GDP standards. 

The position is a member of the Global QA External Operations Leadership team

• Lead and manage QA EU & international (RoW excl North America) consisting of QA Supplier managers., ensuring compliance with GMP/GDP regulations.
• Responsible for a robust and proactive Quality oversight of suppliers in the regions ensuring adherence to all relevant GMP/GDP regulations and effective agreements.
• Ensure products, processes, systems and procedures are in compliance with cGMP/GDP, relevant  authority requirements and global Sobi procedures within the area of responsibility including commercial and clinical products
• Implement quality risk assessment and maintain Quality KPIs of suppliers.
• Oversee QA release of products and drive efficiency in key quality processes.
• Develop and manage functions and people aligned with strategic business goals.
• Prepare and maintain budget adherence.

Qualifications

Join our team as the Global Quality Assurance Leader and demonstrate exceptional personal attributes by leading with confidence, driving proactively, solving complex challenges with finesse, fostering cultural awareness, and motivating for excellence. Make a significant impact in the pharmaceutical industry by applying your visionary leadership and passion for quality assurance. Apply now to shape the future of quality assurance with us

• Master's degree/PhD in pharmacy or relevant field.
• Minimum  15 years' experience from pharmaceutical industry within quality, manufacturing, product development and/or regulatory affairs with leadership experience
• Strong experience in managing external GMP/GDP suppliers
• Strong understanding of regulatory and GMP requirements, external supplier management, and business practices.
• Fluent in English.
• Experience from working in an international organization and across borders and with different cultures

If you are a visionary leader with a drive for excellence and a commitment to quality, we invite you to apply for the Global Quality Assurance Leader position. Take the next step in your career and make a significant impact in the world of pharmaceutical quality assurance. Apply now!

Additional Information

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 i