New · posted Oct 15
Prokidney · Biotechnology
Senior Manager, Validation
- Winston-Salem, NC
- On-site
- Full-time
- Manager
Open until filled
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 you need
- 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
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
What you'll do
- 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
Where you'll work
Winston-Salem, NCOn-siteOpen in Maps (opens in a new tab)
More jobs in Winston-Salem, NCEqual opportunity, accessibility and legal noticesProkidney's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
Manager roles in the US9 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $135,500 | $141,000 | $164,000 |
Comparisons: the base pay employers published on open Validation & CQV roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Validation & CQV
The general path across 111 open Validation & CQV roles on Regulatory Jobs, with the titles they carry most. Not Prokidney's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 29 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership13
- Validation and qualification12
- Data and digital systems6
- GMP and compliance5
- Documentation and SOPs5
- Quality systems and risk4
- Lab testing and methods3
- Investigations and CAPA1
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- European CommissionEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules and annexes
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Prokidney on Regulatory Jobs
- 6
- Open roles
- 6
- Distinct roles
- 1
- Locations
By discipline
- Quality6 100%
By level
- Director4 67%
- Manager1 17%
- Senior & Principal1 17%
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Senior Manager, Validation at Prokidney
Open until filled.