Associate Director, Validation

Prokidney

Winston, United States
On-site
Lead qualification and validation teams
Implement harmonized engineering systems
Author and execute validation documentation
ProKidney is seeking an Associate Director of Validation to lead validation efforts in a biopharmaceutical setting, focusing on establishing systems and processes that drive operational effectiveness and regulatory compliance. The role emphasizes leadership, technical expertise in validation, and collaboration across departments

Job Summary

  • The Associate Director of Validation will lead the Qualification and Validation teams at the site, establishing operational objectives and systems to drive employee engagement and alignment with other departments.
  • Will lead system validation projects related to authoring and executing validation documentation for laboratory instruments/equipment and systems according to ISPE GAMP 5 Validation Life Cycle.
  • Provide leadership and direction to Validation team members, driving performance and value creation to the site function operational and strategic plans and tasks.

Matching Summary

Match Score: 85

ProKidney is seeking an Associate Director of Validation to lead validation efforts in a biopharmaceutical setting, focusing on establishing systems and processes that drive operational effectiveness and regulatory compliance. The role emphasizes leadership, technical expertise in validation, and collaboration across departments.

Skills & Requirements

Must-have

  • Lead Qualification and Validation teams
  • Implement harmonized engineering systems
  • Author and execute validation documentation
  • Data Integrity Assessment
  • GMP and regulatory agency inspections

Nice-to-have

  • Drive employee engagement and alignment
  • Continuous improvement of team culture
  • Develop strong partner relationships

Key Requirements

  • Bachelor's degree in Life Sciences or Engineering
  • 10+ years experience in biopharmaceutical/related engineering or quality
  • 5+ years leadership experience
  • Expert knowledge of GxPs, GAMP, CFRs/Annex 11, Data Integrity
  • Experience with calibration and maintenance management software
  • Knowledge of electronic document management systems
  • Ability to manage multiple projects simultaneously

Work Rights

Must be eligible to work in the US

Tailored Resume

Cover Letter