{"id":3007297,"url":"https://alion.io/job/prokidney-associate-director-it-gxp-quality-systems","title":"Associate Director, IT GxP & Quality Systems","company":{"id":7427,"name":"ProKidney","domain":"prokidney.com","url":"https://alion.io/company/prokidney","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Leadership","role_family":"Leadership","seniority":"head","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Winston-Salem, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":141000,"max_usd":265000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":2576},"experience_years_min":10,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"LIMS","optional":false},{"name":"Veeva","optional":false},{"name":"GMP","optional":true}],"status":"live","first_seen_at":"2026-09-29T21:23:37Z","employer_posted_date":"2026-10-19","last_verified_at":"2026-10-24T12:02:18Z","board_verified":true,"closed_at":null,"days_open":24,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":24},"description":"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.\nThe 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.\nKey Responsibilities:\nGxP & Quality Systems Leadership\nLead the Enterprise GxP and Quality Systems portfolio, including strategy execution, governance, delivery, operations, support, and lifecycle management.\nOwn the Quality Management Systems environment, including roadmap execution, enhancements, integrations, system administration, and ongoing optimization.\nDrive process harmonization, automation, continuous improvement initiatives, and future-state Quality Systems.\nLead strategic technology programs supporting Quality, Clinical, Manufacturing, Regulatory, and Technical Operations functions\nTechnology Delivery & Portfolio Management\nOversee implementation, enhancement, integration, validation, release, and support activities across the GxP application portfolio.\nManage technology priorities, roadmaps, vendor deliverables, and system lifecycle activities to ensure reliable business operations.\nPartner with business stakeholders to translate operational requirements into scalable and compliant technology solutions.\nRecommend technology improvements and business process enhancements that improve efficiency, compliance, and user experience.\n\nCompliance & Validation\nEnsure compliance with applicable GxP regulations, including FDA 21 CFR Part 11, EU Annex 11, data integrity requirements, and CSV/CSA expectations.\nMaintain inspection readiness across the Quality Systems landscape and support regulatory inspections, audits, and compliance assessments.\nEstablish appropriate governance, system controls, audit trail requirements, electronic signature controls, user access structures, and data ownership standards.\nCross-Functional Leadership\nLead cross-functional teams and strategic initiatives involving Quality, Clinical, Regulatory, Manufacturing, and Information Technology stakeholders.\nInfluence 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.\nCoordinate priorities across functional partners to ensure alignment between business objectives and technology delivery.\nCoach project teams and technology partners on Quality Systems best practices, compliance expectations, and governance standards.\nVendor & Partner Management\nManage technology vendors, consultants, implementation partners, and service providers to ensure quality delivery and achievement of business objectives.\nMonitor vendor performance, service quality, project outcomes, and contractual obligations.\nSupport budgeting, forecasting, and resource planning activities related to the GxP application portfolio.\n\nQualifications:\nEducation/Training:Bachelor’s degree in Life Sciences, Pharmacy, Engineering, IT, or related field.\n10+ years of experience in pharmaceutical, biotechnology, medical device, or other regulated industries.\n\nExperience: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.\nStrong hands-on experience with Quality Management Systems; MasterControl, Veeva, LabVantage LIMS, is required\nPast Experience with managing clinical systems or interacting with clinical operations and clinical sites towards supporting their needs would be a plus.\nExperience 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.\nDemonstrated experience leading QMS implementations, system configurations, and continuous improvement initiatives.\nExperience managing GxP application portfolios, vendors, and implementation partners.\nExperience with enterprise-wide deployment and support of quality management.\nExperience with broader Quality IT portfolio (LabVantage, LIMS).\n\n Knowledge:Deep understanding of pharmaceutical Quality processes, GxP requirements, and the technology supporting regulated business processes.\nStrong knowledge of computerized system validation/assurance (CSV/CSA), data integrity, electronic records, audit trails, and quality risk management.\nKnowledge of cGMP facilities and cGMP requirements.\n\n Skills:Excellent stakeholder, program management, communication, and leadership skills.\nMust 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.\nAbility to exercise judgment within defined procedures and practices to determine appropriate action.\nDetail oriented with strong analytical and problem-solving skills.\nExcellent communication skills with the ability to collaborate effectively with cross-functional teams and stakeholders.\nExpected to keep up to date on regulatory changes for data integrity, US FDA 21 CFR Part 11 and EU Annex 11 compliance.\n\nProKidney 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.\nApplicants must be eligible to work in the United States without the need for work visa or residency sponsorship.","description_format":"text","description_chars":6834,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Cell & Gene Therapy","Regenerative Medicine"],"lifecycle":[{"event":"open","at":"2026-10-21T14:15:12Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 1","filings_12m":1,"filings_prev_12m":2,"green_card_filings_12m":0,"median_offered_wage_usd":107500,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":76,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.843,"p_room":0.9,"age_days":24,"expected_fill_days":36,"reasons":["conf:2","win:mid"],"computed_at":"2026-10-24T06:02:35Z"},"pay":null,"html_url":"https://alion.io/job/prokidney-associate-director-it-gxp-quality-systems","json_url":"https://alion.io/job/prokidney-associate-director-it-gxp-quality-systems.json","meta":{"generated_at":"2026-10-24T13:50:04Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per 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