Manager, QA Product Disposition

Position Summary

The Manager, Quality Assurance, will oversee quality assurance for Ultragenyx’s Gene Therapy products across all manufacturing stages. Key responsibilities include managing batch documentation, leading disposition activities, and supporting regulatory inspections.

Responsibilities

• Manage and independently review batch documentation for investigational and commercial products.
• Lead and support disposition-related quality activities across internal and external manufacturing sites.
• Manage queries from Qualified Persons (QPs) to ensure timely batch certification and PSF maintenance.
• Lead disposition activities for new product introductions and country launches.
• Manage and execute Quality Management transactions in Oracle for timely product release.
• Support and collaborate with the Sr. Director in monitoring and reporting disposition metrics.
• Represent QA in cross-functional forums and contribute to global disposition strategy.
• Escalate quality risks and issues effectively.
• Contribute to the development and refinement of SOPs and quality system documentation.

Requirements

• Bachelor’s degree in a scientific or technical discipline required.
• 7+ years of experience in a GxP-regulated pharmaceutical or biotechnology environment.
• Strong expertise with product disposition, batch record review, or QA operations.
• Familiarity with cGMP regulations and quality systems (US/EU).
• Experience with Oracle or similar ERP systems is highly desirable.
• Strong organizational, communication, and problem-solving skills.
• Ability to lead through influence and manage complex projects independently.
• Experience with Veeva eQMS is a plus.

Pay Range

The typical annual salary range for this full-time position is $131,800 USD - $162,900 USD.

Benefits

• Generous vacation time and public holidays
• Volunteer days
• Long-term incentive and Employee stock purchase plans or equivalent offerings
• Employee wellbeing benefits
• Fitness reimbursement
• Tuition sponsorship
• Professional development plans

About the Role

At Ultragenyx, we believe in taking real impactful action to care for rare disease patients and our people. We aim to lead the future of rare disease medicine by challenging the status quo and creating innovative medicines at fair prices.

Qualifications

We value a diverse workforce and are committed to providing equal opportunities for all applicants. We prohibit unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws.