Ultragenyxpharmaceutical

Manager, QA Product Disposition

Bedford, MA

Sponsorship not specifiedDetected 6 days ago
Supply ChainERPGMPCRISPRCommunicationCollaborationGxP

About the role

  • ultra innovative - Tackle rare and dynamic challenges
  • The Manager, Quality Assurance, will provide quality assurance oversight for the timely disposition of Ultragenyx's Gene Therapy products across all stages of manufacturing.
  • Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

Responsibilities

  • Manage and independently review batch documentation for investigational and commercial products.
  • Manage queries from internal and external Qualified Persons (QPs), to ensure timely batch certification, QP declarations, and maintenance of the Product Specification File (PSF).
  • Lead disposition activities for new product introductions and new country launches in collaboration with CMC, Regulatory, and Supply Chain teams.
  • Manage and execute Quality Management transactions in Oracle to support timely product release.
  • Support and collaborate with the Sr. Director in monitoring and reporting disposition metrics
  • Support regulatory inspections and internal audits as a subject matter expert for product disposition.
  • Support and collaborate with the Sr. Director in monitoring and reporting disposition metrics; assist in identifying trends and implementing initiatives to improve cycle time and right-first-time performance.

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.

Benefits

  • To achieve this goal, our vision is to lead the future of rare disease medicine.
  • For us, this means going where other biopharma companies won't go - challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments.
  • We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside of work.

Company info

  • At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do.
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