Senior Validation Leader, GMP & FDA Compliance

ProKidney; Winston-Salem (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

ProKidney, located in Winston-Salem, NC, seeks a Sr. Manager of Validation to lead the on-site Validation team and drive end-to-end validation programs in line with GAMP 5 and FDA guidance.

You will mentor staff, coordinate cross‑functional projects with QA, Manufacturing, and Engineering, and ensure robust documentation and compliance across IQ/OQ/PQ, risk assessments, and RTMs. The role requires strong leadership, hands-on expertise, and a deep understanding of cGMP and data integrity to

Qualifications

• Bachelor’s degree in Life Sciences or Engineering.
• 7+ years in biopharma or related field with 3+ years in a leadership role.
• Expert knowledge of GxPs, GAMP, CFRs/Annex 11, and Data Integrity for lab systems and equipment.
• Strong understanding of Validation Lifecycle (GAMP 5).
• Experience with calibration and maintenance management software.
• Knowledge of electronic document management systems.
• Experience with data integrity practices and compliance.
• Strong technical writing skills for qualification docs, SOPs, and work instructions.
• Ability to manage multiple projects with minimal supervision.
• Detail-oriented with excellent verbal and written communication abilities.
• Adaptable to changing priorities in a deadline-driven environment.
• Hands-on experience with regulatory expectations for controls, automation and computer system validation.
• Knowledge of pharmaceutical equipment (centrifuges, HVAC, chillers, steam generators, temp-controlled units) is advantageous.
• Knowledge of cGMP, root cause analysis, risk assessment and investigation tools/techniques.
• Experience in writing computer system test scripts, validation protocols and summary reports.

Responsibilities

• Provide leadership to Validation team and drive performance.
• Ensure adequate resourcing to meet site objectives; partner with Director of Validation for solutions.
• Interact with cross-functional leaders on multi-department projects.
• Contribute to and improve the culture of the Validation team and site.
• Support validation representation during GMP inspections.
• Identify areas to improve project delivery and reduce costs; support investment strategies.
• Hands-on troubleshooting and problem solving on the shop floor.
• Lead continuous improvement projects and mentor staff.
• Delegate work and build competence through coaching.
• Drive cross-functional collaboration with QA, Manufacturing, Engineering, etc.
• Provide leadership to deliver site validation strategy.

Skills

GxP knowledge

GAMP 5

Data integrity

Project management

Technical writing

Communication skills

Regulatory compliance

Education

Bachelor’s degree in Life Sciences or Engineering

Tools

Calibration & maintenance software

Electronic document management systems

Job description

ProKidney, located in Winston-Salem, NC, seeks a Sr. Manager of Validation to lead the on-site Validation team and drive end-to-end validation programs in line with GAMP 5 and FDA guidance.

You will mentor staff, coordinate cross‑functional projects with QA, Manufacturing, and Engineering, and ensure robust documentation and compliance across IQ/OQ/PQ, risk assessments, and RTMs. The role requires strong leadership, hands-on expertise, and a deep understanding of cGMP and data integrity to