Senior Manager, Validation

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

Winston-Salem, North Carolina, United States

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
• Supports Validation representation during GMP and other regulatory agency inspections (FDA, CDC, OSHA, etc.) under the direction of the Director of Validation
• Identify areas to improve project delivery efficiency and reduce operational costs; bring forward recommendations and support implementation of approved investment strategies
• Hands‑on troubleshooting and problem solving at the Gemba in support of Validation team members and operations
• Develop and lead small to medium‑sized continuous improvement projects; remain actively involved in projects led by staff members
• Effectively delegate work and build confidence and competence within direct reports through coaching and mentorship
• Drive engagement in the technical and personal development of Validation team members
• Develop strong cross‑functional relationships with partners (QA, Manufacturing, Engineering, etc.) and model collaborative behaviors for all team members
• Provide effective cross‑functional leadership to support delivery of site objectives in alignment with the site validation strategy

Qualifications

• 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
• Expert knowledge of GxPs, GAMP, CFRs/Annex 11, and Data Integrity requirements for laboratory systems and equipment (Understanding of data integrity principles and security controls including, but not limited to audit trail reviews, user access roles, disaster recovery, business continuity, system implementation, change control, archival, retirement, etc)
• 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
• Strong technical writing skills for qualification documents, SOPs, and work instructions
• Ability to manage multiple projects simultaneously with minimal supervision
• Detail‑oriented with excellent verbal and written communication abilities
• Ability to adapt to changing priorities in a deadline‑oriented environment
• Significant hands‑on experience and regulatory expectations knowledge with controls, automation and computer system validation.
• Knowledge of pharmaceutical equipment, such as centrifuges, HVAC systems, building chillers, clean steam generators, and Temperature Controlled Units (e.g. refrigerators, freezers, and incubators) is an advantage.
• Strong knowledge and experience in cGMP, root cause analysis, risk assessment and investigation tools/techniques.
• Experience in writing computer system test scripts, validation protocols and summary reports

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.