Head of Quality North America

Company Description

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

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.

Our Mission And Culture At Sobi North America 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
• Generous time off policy
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

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.

• 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

You are a seasoned Quality leader who combines deep regulatory expertise with strong business acumen and genuine people leadership. You’re comfortable operating at executive level, yet equally committed to coaching leaders and teams to grow, thrive, and take ownership.

You bring calm and clarity to complex situations, make sound risk‑based decisions, and lead with integrity — especially when it matters most, such as during inspections or critical quality events. You enjoy working in global, matrix organizations and know how to balance regional accountability with global alignment.

Above all, you are motivated by purpose
. You care deeply about patient safety, believe in building a strong Quality culture, and want your work to make a meaningful difference.

• Master’s degree (or higher) in Life Sciences, Pharmacy, Chemistry, Biotechnology, Engineering, or similar
• 15+ years’ experience in pharmaceutical or biotech Quality roles
• 5+ years of people leadership with a proven ability to build and develop strong teams
• Extensive GMP experience, with solid working knowledge of GDP, GCP, and GVP
• Proven leadership during FDA inspections and direct interaction with health authorities
• Strong experience overseeing external manufacturers and partners in a global matrix environment
• Ability to influence senior stakeholders and navigate complex, cross‑functional organizations

Here at Sobi we live by our core values:
Care, Ambition, Urgency, Ownership and Partnership!

At Sobi, we are dedicated to…