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Senior Manager, Validation

ProKidney
Location
Winston-Salem, North Carolina, United States
Posted
19 days ago
Department
Validation
What they actually want (must-haves)
  • Bachelor’s degree in Life Sciences or Engineering
  • Minimum of 7 years of experience in a biopharmaceutical or related environment
  • At least 3 years in a leadership role
  • Expert knowledge of GxPs, GAMP, CFRs/Annex 11, and Data Integrity requirements
  • Strong understanding of Validation Lifecycle (GAMP 5) principles
  • Experience with calibration and maintenance management software
Nice to have
  • Knowledge of pharmaceutical equipment such as centrifuges, HVAC systems, building chillers, clean steam generators, and Temperature Controlled Units
What the job really is

The Senior Manager of Validation will lead the on-site Validation team at ProKidney, focusing on both leadership and hands-on technical contributions. Responsibilities include establishing operational objectives, managing validation documentation, driving cross-functional collaboration, and supporting regulatory inspections. The role also emphasizes continuous improvement and coaching team members to enhance performance and efficiency.

Things to weigh
  • No salary listed
  • Role requires significant hands-on troubleshooting and problem-solving
  • Candidates must be eligible to work in the U.S. without sponsorship
  • The position involves managing multiple projects and adapting to changing priorities
Job score2.8/5
Benefits1/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency0/5

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