layiq
/la·yiq/adjective
worthy; deserving; fitting; suitable.
A role, opportunity, or path that merits attention, time, and pursuit.
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Job opportunity
Senior Manager, Validation
ProKidney
Winston-Salem, North Carolina, United States
Source: ProKidney careers · View original posting
Employer job description
From ProKidney's posting. “We” and “our” refer to the employer.
Position Summary
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.
Responsibilities
- 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