{"id":210989,"url":"https://alion.io/job/prokidney-senior-manager-validation","title":"Senior Manager, Validation","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":"HR","role_family":"HR","seniority":"senior","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":76000,"max_usd":153000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":2746},"experience_years_min":7,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"GMP","optional":false}],"status":"closed","first_seen_at":"2026-09-01T19:44:16Z","employer_posted_date":"2026-09-01","last_verified_at":"2026-10-26T18:40:33Z","board_verified":false,"closed_at":"2026-10-26T18:40:33Z","days_open":54,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":54},"description":"Position Summary\nThe Sr. Manager of Validation will lead ProKidney's on-site Validation team, serving as both a people leader and a hands-on technical contributor. In this role, you'll establish operational objectives, drive cross-functional alignment, and lead the full lifecycle of validation documentation - including System Validation Plans, IQ/OQ/PQ protocols, Risk Assessments, Test Scripts, and RTMs - in accordance with GAMP 5, 21 CFR Part 11, and FDA's Computer Software Assurance guidance.\nResponsibilities\nProvide leadership and direction to Validation team members, driving performance and value creation aligned with site operational and strategic goals\nEnsure adequate resourcing (capacity and capability) to accomplish site objectives; identify and recommend solutions to alleviate constraints in partnership with the Director of Validation\nRegularly interacts with cross-functional department leaders on multi-department projects and challenges; supports change initiatives led by senior leadership\nActively contribute to and continuously improve the culture of the Validation team and the broader site\nSupports Validation representation during GMP and other regulatory agency inspections (FDA, CDC, OSHA, etc.) under the direction of the Director of Validation\nIdentify areas to improve project delivery efficiency and reduce operational costs; bring forward recommendations and support implementation of approved investment strategies\nHands-on troubleshooting and problem solving at the Gemba in support of Validation team members and operations\nDevelop and lead small to medium-sized continuous improvement projects; remain actively involved in projects led by staff members\nEffectively delegate work and build confidence and competence within direct reports through coaching and mentorship\nDrive engagement in the technical and personal development of Validation team members\nDevelop strong cross-functional relationships with partners (QA, Manufacturing, Engineering, etc.) and model collaborative behaviors for all team members\nProvide effective cross-functional leadership to support delivery of site objectives in alignment with the site validation strategy\nQualifications\nBachelor’s degree. Preferred Fields of Study: Life Sciences or Engineering\nA minimum of 7 years of experience in a biopharmaceutical or related environment in an engineering or quality related role, with at least 3 years in a leadership role\nExpert knowledge of GxPs, GAMP, CFRs/Annex 11, and Data Integrity requirements for laboratory systems and equipment (Understanding of data integrity principles and security controls including, but not limited to audit trail reviews, user access roles, disaster recovery, business continuity, system implementation, change control, archival, retirement, etc)\nStrong understanding of Validation Lifecycle (GAMP 5) principles\nExperience with calibration and maintenance management software\nKnowledge of electronic document management systems\nExperience with data integrity practices and compliance\nStrong technical writing skills for qualification documents, SOPs, and work instructions\nAbility to manage multiple projects simultaneously with minimal supervision\nDetail-oriented with excellent verbal and written communication abilities\nAbility to adapt to changing priorities in a deadline-oriented environment\nSignificant hands-on experience and regulatory expectations knowledge with controls, automation and computer system validation.\nKnowledge of pharmaceutical equipment, such as centrifuges, HVAC systems, building chillers, clean steam generators, and Temperature Controlled Units (e.g. refrigerators, freezers, and incubators) is an advantage.\nStrong knowledge and experience in cGMP, root cause analysis, risk assessment and investigation tools/techniques.\nExperience in writing computer system test scripts, validation protocols and summary reports\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":4366,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":3,"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":["Cell & Gene Therapy","Regenerative Medicine"],"lifecycle":[{"event":"open","at":"2026-09-05T08:21:28Z"},{"event":"close","at":"2026-10-26T18:40:33Z"}],"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":null,"pay":null,"html_url":"https://alion.io/job/prokidney-senior-manager-validation","json_url":"https://alion.io/job/prokidney-senior-manager-validation.json","meta":{"generated_at":"2026-10-26T22:51:46Z","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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