Head of Quality North America

Company: Sobi
Location: Raleigh
Posted on: February 22, 2026

Job Description:

Job Description Job Description 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 Job Description 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 Qualifications About you 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. Key talents and experience 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! Additional Information Compensation and Total Rewards at Sobi At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards. Your total compensation at Sobi goes beyond just your base salary and annual bonus. It also includes a robust suite of benefits, such as: 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. The base salary range for this role is $220,000 – $300,000. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details. 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 1,900 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. An Equal Opportunity Employer Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to irina.conc@sobi.com Know Your Rights

Keywords: Sobi, Durham , Head of Quality North America, Human Resources , Raleigh, North Carolina