Senior Manager, CMC QA β€” Lot Release & Compliance in Bedford

Senior Manager, CMC QA β€” Lot Release & Compliance in Bedford

Bedford Full-Time 60000 - 80000 Β£ / year (est.) No working from home possible
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At a Glance

  • Tasks: Oversee Lot Release system and ensure quality assurance for pharmaceutical products.
  • Company: Ultragenyx Pharmaceutical, a leader in innovative therapies.
  • Benefits: Competitive salary, health benefits, and opportunities for professional growth.
  • Other info: Collaborative culture with a focus on continuous improvement.
  • Why this job: Join a fast-paced environment and make a real impact in the pharmaceutical industry.
  • Qualifications: Extensive GxP validation experience and strong regulatory knowledge required.

The predicted salary is between 60000 - 80000 Β£ per year.

Ultragenyx Pharmaceutical is seeking a Senior Manager, CMC QA to oversee the Lot Release system and QA activities for UGX/UGT product lots. The role ensures on-time dispositions, manages batch records, COA evaluations, and change control, with cross-functional collaboration across TechOps and QA functions.

The candidate will bring extensive GxP validation experience, strong regulatory knowledge, and a proven ability to lead in a fast-paced environment while driving continuous improvement.

Senior Manager, CMC QA β€” Lot Release & Compliance in Bedford employer: Ultragenyx Pharmaceutical

Ultragenyx Pharmaceutical is an exceptional employer that fosters a dynamic and collaborative work culture, where innovation and continuous improvement are at the forefront. Employees benefit from comprehensive professional development opportunities and a commitment to regulatory excellence, all while working in a supportive environment that values their contributions. Located in a vibrant area, Ultragenyx offers a unique chance to be part of a mission-driven team dedicated to advancing therapies for rare diseases.

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Contact Details:

Ultragenyx Pharmaceutical Recruitment Team

We think you need these skills to ace Senior Manager, CMC QA β€” Lot Release & Compliance in Bedford

GxP Validation Experience
Regulatory Knowledge
Lot Release System Management
Batch Record Management
COA Evaluations
Change Control Management
Cross-Functional Collaboration