Head of Quality North America

At Sobi quality is not a function its 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 highimpact 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 rightfirsttime execution
• Build develop and inspire highperforming 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. Youre 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 riskbased 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

• Masters 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 crossfunctional 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 $220000 $300000. 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 Sobis 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 1900 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 were ready to take on the worlds diseases ailments and adversity. Our people believe they have the power to make a positive impact in others lives because thats exactly what we do here. If youre 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 cant 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.

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Remote Work :

Yes

Employment Type :

Full-time