Associate Director, IT GxP & Quality Systems at Prokidney · Winston-S…

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.
• Lead validation activities including requirements management, risk assessments, testing strategy, traceability, validation documentation, and release readiness.
• 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 GxP and Quality 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 experience strongly preferred.
  • 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.
  • Experience with other leading industry platforms such as Veeva is highly desirable.
  • 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.