Head of QA EU & International

SOBI -Swedish Orphan Biovitrum AB

Sweden - Stockholm

Apply now The time has come for you to join an expansive journey within the quality function at Sobi. If you have a proven track record in leadership, excellent communication skills, and solid experience in quality and biologicals, apply as soon as possible.
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 the 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 Sobi.

• 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 as soon as you can.

The Company
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.

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 Sobi?

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.

The next step - your application
If you find this position intriguing and wish to learn more about its potential impact on your career, we encourage you to apply today or reach out to Kristina Edholm (Sr Recruitment Manager) at PharmaRelations for a confidential discussion.