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Sr. Director, Quality Operations

ProKidney
Location
Winston-Salem, North Carolina, United States
Posted
19 days ago
Department
Quality Management
What they actually want (must-haves)
  • Bachelor’s degree in a scientific or allied health field
  • 10+ years of Sterile manufacturing work experience on the quality side
  • Extensive GMP operational experience overseeing investigational drug manufacturing
  • Demonstrated Quality leadership with a strong partnership approach to Manufacturing
  • Proven ability to build, lead, and develop high-performing GMP Quality Assurance teams
  • Deep knowledge of GMP, FDA, and EMA regulatory requirements for biologics
What the job really is

The Senior Director of Quality Operations is responsible for leading GMP Quality Assurance for ProKidney's drug products across all manufacturing sites. This role involves overseeing quality operations, ensuring compliance with regulatory requirements, and managing quality systems to support both clinical and commercial manufacturing. The position also includes mentoring staff, leading audits, and addressing product quality issues while fostering collaboration across various teams.

Things to weigh
  • No salary listed
  • Role involves significant leadership and oversight responsibilities
  • Requires extensive experience in a highly regulated environment
  • Candidates must be eligible to work in the U.S. without sponsorship
Job score3/5
Benefits1/5
Freshness4/5
Career value5/5
Role clarity5/5
Pay transparency0/5

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