ProKidney

Develops cell therapy to treat CKD

Associate Director, IT GxP & Quality Systems

Enterprise ApplicationsConfirmed live in the last 24 hours

Full-timeWinston-Salem, NC, USANo salary listedIn-person

About the Job

Requirements

A bachelor's degree in Life Sciences, Pharmacy, Engineering, IT, or a related field is required.
At least 10 years of experience in pharmaceutical, biotechnology, medical device, or another regulated industry is required, including at least 10 years managing digital capabilities.
Significant experience leading implementation, management, and support of GxP and Quality IT Systems in a pharmaceutical, biotechnology, or other regulated life sciences environment is required.
Strong hands-on experience with Quality Management Systems is required, including MasterControl, Veeva, and LabVantage LIMS.
Experience with GxP platforms supporting Quality, clinical operations, cell and gene therapy, chain of identity/chain of custody, or other regulated business processes is required.
Demonstrated experience leading QMS implementations, system configurations, and continuous improvement initiatives is required.
Experience managing GxP application portfolios, vendors, and implementation partners is required.
Experience with enterprise-wide deployment and support of quality management is required.
Experience with the broader Quality IT portfolio, including LabVantage and LIMS, is required.
Deep understanding of pharmaceutical Quality processes, GxP requirements, and the technology supporting regulated business processes is required.
Strong knowledge of computerized system validation/assurance (CSV/CSA), data integrity, electronic records, audit trails, and quality risk management is required.
Knowledge of cGMP facilities and cGMP requirements is required.
Strong stakeholder, program management, communication, and leadership skills are required.
Strong organizational skills and the ability to manage and prioritize multiple projects or assignments, follow them through to completion, and meet deadlines are required.
The ability to exercise judgment within defined procedures and practices to determine appropriate action is required.
Detail orientation and strong analytical and problem-solving skills are required.
The ability to collaborate effectively with cross-functional teams and stakeholders is required.
Applicants must be eligible to work in the United States without work visa or residency sponsorship.

Responsibilities

Lead the Enterprise GxP and Quality Systems portfolio, including strategy execution, governance, delivery, operations, support, and lifecycle management.
Own the Quality Management Systems environment, including roadmap execution, enhancements, integrations, system administration, and ongoing optimization.
Drive process harmonization, automation, continuous improvement initiatives, and future-state Quality Systems.
Lead strategic technology programs supporting Quality, Clinical, Manufacturing, Regulatory, and Technical Operations functions.
Oversee implementation, enhancement, integration, validation, release, and support activities across the GxP application portfolio.
Manage technology priorities, roadmaps, vendor deliverables, and system lifecycle activities to ensure reliable business operations.
Partner with business stakeholders to translate operational requirements into scalable and compliant technology solutions.
Recommend technology improvements and business process enhancements that improve efficiency, compliance, and user experience.
Ensure compliance with applicable GxP regulations, including FDA 21 CFR Part 11, EU Annex 11, data integrity requirements, and CSV/CSA expectations.
Maintain inspection readiness across the Quality Systems landscape and support regulatory inspections, audits, and compliance assessments.
Establish governance, system controls, audit trail requirements, electronic signature controls, user access structures, and data ownership standards.
Lead cross-functional teams and strategic initiatives involving Quality, Clinical, Regulatory, Manufacturing, and Information Technology stakeholders.
Influence decision-making using subject matter expertise in Quality Systems, compliance, validation, and regulated technology environments.
Coordinate priorities across functional partners to align business objectives and technology delivery.
Coach project teams and technology partners on Quality Systems best practices, compliance expectations, and governance standards.
Manage technology vendors, consultants, implementation partners, and service providers to ensure quality delivery and achievement of business objectives.
Monitor vendor performance, service quality, project outcomes, and contractual obligations.
Support budgeting, forecasting, and resource planning activities related to the GxP application portfolio.
Keep up to date on regulatory changes for data integrity, US FDA 21 CFR Part 11, and EU Annex 11 compliance.

Desired Qualifications

Experience managing clinical systems or working with clinical operations and clinical sites to support their needs is a plus.
Experience with TrakCel or other market chain-of-identity/chain-of-custody systems is strongly preferred for commercialization.

The Associate Director, IT GxP & Quality Systems, leads strategic programs within the Company's regulated technology landscape and serves as the primary technology partner for Quality Systems. This role is accountable for the delivery, governance, optimization, compliance, and lifecycle management of GxP technology platforms, with primary ownership of the Quality Management Systems (QMS) environment.

The role drives technology solutions that enable compliant business processes across Quality, Clinical, Regulatory, Manufacturing, Technical Operations, and other GxP-regulated functions. The Associate Director connects technology execution with departmental strategy, ensuring systems scale effectively to support the organization's evolving clinical, manufacturing, and commercialization needs. The role leads cross-functional initiatives, manages external partners, and continuously improves Quality Systems capabilities while maintaining regulatory compliance and inspection readiness. The Associate Director level is characterized by leading programs with strategic impact, driving outcomes at scale, and connecting execution to departmental strategy with emphasis to transform processes to support commercialization.

Key Responsibilities:

GxP & Quality Systems Leadership

Lead the Enterprise GxP and Quality Systems portfolio, including strategy execution, governance, delivery, operations, support, and lifecycle management.
Own the Quality Management Systems environment, including roadmap execution, enhancements, integrations, system administration, and ongoing optimization.
Drive process harmonization, automation, continuous improvement initiatives, and future-state Quality Systems.
Lead strategic technology programs supporting Quality, Clinical, Manufacturing, Regulatory, and Technical Operations functions

Technology Delivery & Portfolio Management

Oversee implementation, enhancement, integration, validation, release, and support activities across the GxP application portfolio.
Manage technology priorities, roadmaps, vendor deliverables, and system lifecycle activities to ensure reliable business operations.
Partner with business stakeholders to translate operational requirements into scalable and compliant technology solutions.
Recommend technology improvements and business process enhancements that improve efficiency, compliance, and user experience.

Compliance & Validation

Ensure compliance with applicable GxP regulations, including FDA 21 CFR Part 11, EU Annex 11, data integrity requirements, and CSV/CSA expectations.
Maintain inspection readiness across the Quality Systems landscape and support regulatory inspections, audits, and compliance assessments.
Establish appropriate governance, system controls, audit trail requirements, electronic signature controls, user access structures, and data ownership standards.

Cross-Functional Leadership

Lead cross-functional teams and strategic initiatives involving Quality, Clinical, Regulatory, Manufacturing, and Information Technology stakeholders.
Influence decision-making using subject matter expertise in Quality Systems, compliance, validation, and regulated technology environments. Associate Director roles are expected to provide discipline leadership and drive strategic outcomes within their specialized area.
Coordinate priorities across functional partners to ensure alignment between business objectives and technology delivery.
Coach project teams and technology partners on Quality Systems best practices, compliance expectations, and governance standards.

Vendor & Partner Management

Manage technology vendors, consultants, implementation partners, and service providers to ensure quality delivery and achievement of business objectives.
Monitor vendor performance, service quality, project outcomes, and contractual obligations.
Support budgeting, forecasting, and resource planning activities related to the GxP application portfolio.

Qualifications:

Education/Training:
- Bachelor’s degree in Life Sciences, Pharmacy, Engineering, IT, or related field.
- 10+ years of experience in pharmaceutical, biotechnology, medical device, or other regulated industries.
Experience:
- Significant experience leading implementation, management and support of GxP and Quality IT Systems within a pharmaceutical, biotechnology, or other regulated life sciences environment. At least 10 plus in management of digital capabilities.
- Strong hands-on experience with Quality Management Systems; MasterControl, Veeva, LabVantage LIMS, is required
- Past Experience with managing clinical systems or interacting with clinical operations and clinical sites towards supporting their needs would be a plus.
- Experience with GxP platforms supporting Quality, clinical operations, cell and gene therapy, chain of identity/chain of custody, or other regulated business processes; TrakCel or other market chain of identity/chain of custody experience strongly preferred for commercialization.
- Demonstrated experience leading QMS implementations, system configurations, and continuous improvement initiatives.
- Experience managing GxP application portfolios, vendors, and implementation partners.
- Experience with enterprise-wide deployment and support of quality management.
- Experience with broader Quality IT portfolio (LabVantage, LIMS).

Knowledge:
- Deep understanding of pharmaceutical Quality processes, GxP requirements, and the technology supporting regulated business processes.
- Strong knowledge of computerized system validation/assurance (CSV/CSA), data integrity, electronic records, audit trails, and quality risk management.
- Knowledge of cGMP facilities and cGMP requirements.

Skills:
- Excellent stakeholder, program management, communication, and leadership skills.
- Must have strong organizational skills and be able to manage and prioritize multiple projects or assignments at one time, including the ability to follow assignments through completion and meet deadlines.
- Ability to exercise judgment within defined procedures and practices to determine appropriate action.
- Detail oriented with strong analytical and problem-solving skills.
- Excellent communication skills with the ability to collaborate effectively with cross-functional teams and stakeholders.
- Expected to keep up to date on regulatory changes for data integrity, US FDA 21 CFR Part 11 and EU Annex 11 compliance.

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.

About the Company

ProKidney

Develops cell therapy to treat CKD

ProKidney develops rilparencel, a cell therapy designed to preserve kidney function in patients with advanced chronic kidney disease (CKD). The product is in late-stage clinical trials, and the goal is to delay or potentially avoid the need for dialysis by slowing the loss of kidney function. The treatment works by using transplanted or administered cells to support kidney tissue and function, offering a therapeutic option beyond standard care. ProKidney plans to commercialize rilparencel through sales to healthcare providers and direct-to-patient access, with potential partnerships with providers and insurers to expand access. The company differentiates itself by pursuing a first-in-class cell therapy specifically for CKD and focusing on a large, underserved patient population in the United States. Its mission is to transform CKD care by providing a treatment that preserves kidney function and reduces the burden of dialysis for millions of patients.

Company size: 201-500
Company stage: IPO
Headquarters: Winston-Salem, NC
Founded: 2015

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