ProKidney offers treatment of chronic kidney disease (CKD) through innovations in cellular therapy. Backed by North Carolina Biotechnology Center.
About the role
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.
What they're looking for
- Education/Training:
- 10+ years of experience in pharmaceutical, biotechnology, medical device, or other regulated industries
- Experience:
- Strong hands-on experience with Quality Management Systems, MasterControl experience strongly preferred
- Experience with other leading industry platforms such as Veeva is highly desirable
- Demonstrated experience leading QMS implementations, system configurations, and continuous improvement initiatives
More about this role
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...
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