Associate Director, IT GxP & Quality Systems

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.

Requirements

• 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.
• Detail oriented with strong analytical and problem-solving skills.

Preferred

• 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.
• 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

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.

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.

Ability to exercise judgment within defined procedures and practices to determine appropriate action.

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.