ProKidney offers treatment of chronic kidney disease (CKD) through innovations in cellular therapy. Backed by North Carolina Biotechnology Center.
About the role
The Sr. Manager of Validation will lead ProKidney's on-site Validation team, serving as both a people leader and a hands-on technical contributor. In this role, you'll establish operational objectives, drive cross-functional alignment, and lead the full lifecycle of validation documentation — including System Validation Plans, IQ/OQ/PQ protocols, Risk Assessments, Test Scripts, and RTMs — in accordance with GAMP 5, 21 CFR Part 11, and FDA's Computer Software Assurance guidance.
What they're looking for
- Bachelor’s degree. Preferred Fields of Study: Life Sciences or Engineering
- A minimum of 7 years of experience in a biopharmaceutical or related environment in an engineering or quality related role, with at least 3 years in a leadership role
- Strong understanding of Validation Lifecycle (GAMP 5) principles
- Experience with calibration and maintenance management software
- Knowledge of electronic document management systems
- Experience with data integrity practices and compliance
More about this role
The Sr. Manager of Validation will lead ProKidney's on-site Validation team, serving as both a people leader and a hands-on technical contributor. In this role, you'll establish operational objectives, drive cross-functional alignment, and lead the full lifecycle of validation documentation — including System Validation Plans, IQ/OQ/PQ protocols, Risk Assessments, Test Scripts, and RTMs — in accordance with GAMP 5, 21 CFR Part 11, and FDA's Computer Software Assurance guidance.
- Provide leadership and direction to Validation team members, driving performance and value creation aligned with site operational and strategic goals
- Ensure adequate resourcing (capacity and capability) to accomplish site objectives; identify and recommend solutions to alleviate constraints in partnership with the Director of Validation
- Regularly interacts with cross-functional department leaders on multi-department projects and challenges; supports change initiatives led by senior leadership
- Actively contribute to and continuously improve the culture of the Validation team and the broader site
- Supports Validation representation during GMP and other regulatory agency inspections (FDA, CDC, OSHA,...
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