Head of Quality North America

At Sobi, quality is not a function — it’s a promise to patients. As Head of Quality North America, you will play a pivotal role in ensuring that promise is delivered every single day. This is a senior, high‑impact leadership role where your expertise, judgment, and ability to inspire others will directly influence patient safety, regulatory trust, and business success across the region.

You will be the most senior Quality leader in North America, a trusted partner to global leadership, and the primary Quality voice with FDA and other health authorities — all while building a strong, engaged Quality organization that is proud of the standards it sets.

The position is Hybrid, based in our office in North Carolina, Raleigh, reporting to Chief Quality Officer.

Your impact will include:

In this role, you will:

• Set the quality vision and governance for North America, ensuring alignment with global strategy and regulatory expectations
• Act as the senior Quality interface with FDA, Health Canada, and regional authorities, leading inspections with confidence and credibility
• Drive inspection readiness and compliance excellence across all GxP areas (GMP, GDP, GCP, GVP)
• Ensure robust product quality and supply continuity, from batch disposition to market release
• Provide strategic oversight of external manufacturing partners, suppliers, and logistics providers
• Lead continuous improvement initiatives that strengthen quality culture, data integrity, and right‑first‑time execution
• Build, develop, and inspire high‑performing Quality teams across North America