Head of Quality North America

Sobi•Raleigh, NC

15d•$220,000 - $300,000•Hybrid

About The Position

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:

Requirements

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

Responsibilities

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

Benefits

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
A competitive 401(k) match to support your financial future.
Tuition and wellness reimbursements to invest in your personal and professional growth.
A comprehensive medical, dental, and vision package to prioritize your health and well-being.
Additional recognition awards to celebrate your achievements.