Head of Global QA External Operations

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.

So join us at Sobi, where your unique talents contribute to transforming the lives of people with rare diseases. As a key member of our Global Quality Leadership team, you will lead Global QA External Operations, ensuring GxP compliance and quality oversight across our external supplier network. This role requires a proactive approach to identify opportunities and risks in Sobi's product lifecycle while driving operational excellence.

Job Description

• Lead and manage Global QA External Operations team, ensuring robust quality oversight of external suppliers for manufacturing and analytical testing.
• Oversight of supplier compliance and agreements, including quality risk assessment and KPI management.
• Responsible for QP release, quality operations, and regulatory compliance for clinical and commercial products.
• Coordinate QA activities, drive efficiency improvements, and harmonize processes cross-functionally.
• Develop and manage a proactive Quality organization to meet evolving business needs.
• Participate in strategic planning and lead quality initiatives to support Sobi's objectives.

Qualifications

As the Head of Global QA External Operations at Sobi, we seek a visionary leader with strong interpersonal skills and a proactive mindset. You should possess excellent collaboration skills, be results-oriented, and have the ability to solve complex problems. Your role will require you to handle conflicts effectively, create win-win situations, and demonstrate cultural awareness. With a holistic understanding of business and a focus on courage, empathy, trust, and motivation, you will lead with integrity and drive success in a dynamic global environment.

• Master's degree/PhD in pharmacy or relevant field.
• Minimum 15 years' experience in pharmaceutical quality, leadership, and regulatory affairs.
• Strong knowledge of GMP requirements, supplier management, and business practices in a global environment with focus on US, EU and APAC.
• Strong experience in operating and leading in a international environment including senior stakeholder management.
• Fluent in English.

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 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 ho