{"id":2652316,"url":"https://alion.io/job/vandenboomassociates-gxp-it-validation-lead","title":"GxP IT Validation Lead","company":{"id":4600,"name":"Vandenboomassociates","domain":"vandenboomassociates.com","url":"https://alion.io/company/vandenboomassociates","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Ashby","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"lead","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":[],"countries":[],"hiring_countries":["US"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":124000,"max_usd":234000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":11},"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"Azure","optional":false},{"name":"LIMS","optional":false},{"name":"SharePoint","optional":false},{"name":"SOC 2","optional":false},{"name":"Veeva","optional":false}],"status":"live","first_seen_at":"2026-10-15T18:53:16Z","employer_posted_date":"2026-10-15","last_verified_at":"2026-11-03T11:12:51Z","board_verified":true,"closed_at":null,"days_open":18,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":18},"description":"About the Role\nOur IT Services practice provides managed IT, cybersecurity, and regulated-industry compliance services to life sciences and biotech companies, from seed stage through public companies. We help clients implement technology, operate it reliably, and demonstrate that the controls supporting regulated work are effective.\nThe Opportunity\nWe are looking for an experienced, hands-on GxP IT validation professional who can lead validation engagements and help clients keep computerized systems in a validated, inspection-ready state.\n\nYou will personally scope, write, execute, and document risk-based validation work for SaaS and cloud applications, computerized systems, and supporting IT infrastructure. You will work closely with client Quality Assurance (QA), system owners, and our IT delivery team to establish intended use, assess risk, and produce clear, defensible validation records.\n\nClient QA retains approval authority for validation deliverables and GxP change decisions. You lead execution, recommend the appropriate scope, and explain the technical rationale.\n\nThis role offers a path toward broader technical and practice leadership as the service grows. The initial priority is excellent validation delivery and ongoing GxP IT compliance. Prior experience building a consulting practice or managing a department is welcome but is not required.\n\nKey Responsibilities\nLead validation engagements\nDefine intended use, system boundaries, GxP impact, and risk-based validation scope with client QA and system owners.\n\nPrepare and execute validation plans, requirements, risk assessments, test protocols, traceability records, and summary reports appropriate to each system and its intended use.\n\nApply risk-based CSV and applicable computer software assurance principles, using supplier documentation and testing where justified.\n\nAssess SaaS and cloud systems used in regulated work, such as eQMS, eSignature, LIMS, eTMF, and document management platforms.\n\nAssess Microsoft 365 or SharePoint configurations when clients intend to use them for GxP records or workflows.\n\nPlan and document qualification of supporting IT infrastructure, including relevant server, network, cloud, backup, and disaster recovery capabilities, in collaboration with technical specialists.\n\nExplain validation decisions and resolve review comments with client QA.\n\nMaintain the validated state\nMaintain system inventories, validation status records, and scheduled review activities for assigned clients.\n\nAssess changes, vendor releases, and system updates for GxP impact and recommend proportionate testing and documentation.\n\nPerform or coordinate periodic reviews, supplier assessments, and audit trail reviews within the agreed scope and client-approved procedures.\n\nAssess electronic record and signature controls, access management, audit trails, retention, and data integrity against applicable requirements and intended use.\n\nIdentify gaps, document risks, and track agreed remediation actions with accountable owners.\n\nSupport audits and inspections\nPrepare validation records and IT control evidence for client QA reviews, sponsor audits, supplier audits, and regulatory inspections.\n\nExplain work you have performed and the rationale supporting validation scope and testing decisions.\n\nSupport responses to observations and follow remediation actions through closure.\n\nEscalate compliance concerns, delivery constraints, and unresolved risks promptly.\n\nImprove delivery\nMaintain practical SOPs, templates, and validation methods that support consistent, risk-based delivery.\n\nEstimate effort for validation engagements with practice leadership.\n\nCoordinate assigned work with IT engineers, compliance staff, and specialist consultants.\n\nProvide technical guidance and review work within your area of expertise.\n\nHelp train IT staff on the GxP procedures relevant to their assigned work.\n\nTrack delivery effort and identify opportunities to improve quality and efficiency.\n\nPractice leadership retains responsibility for commercial pricing, sales commitments, staffing decisions, and overall service portfolio ownership. This role may support SOX ITGC or SOC 2 engagements within demonstrated competence, with specialist involvement coordinated by practice leadership. These areas are secondary to the role's GxP validation responsibilities.\nQualifications\nRequired\nSubstantial hands-on experience in GxP computerized system validation or IT quality within life sciences. Typically seven or more years of relevant experience, with demonstrated delivery capability carrying more weight than a specific tenure threshold.\n\nPersonal ownership of validation engagements, including authoring deliverables, executing or coordinating testing, resolving QA comments, and completing approved validation packages.\n\nPractical knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity principles including ALCOA+, and risk-based validation and assurance methods.\n\nExperience validating regulated SaaS, cloud-hosted applications, or other computerized systems, with an understanding of the supporting IT infrastructure and shared responsibilities.\n\nAbility to distinguish GxP impact, intended use, and system risk, and translate those judgments into a justified validation approach.\n\nExperience maintaining validated systems through change control, release assessments, or periodic reviews.\n\nExperience supporting a QA review, sponsor audit, supplier audit, external audit, or regulatory inspection involving computerized systems or IT controls.\n\nStrong technical writing, client communication, and organizational skills, with the ability to manage several concurrent assignments.\n\nUS work authorization and residence in the United States.\n\nPreferred\nConsulting or managed-services experience supporting multiple life sciences clients.\n\nIT infrastructure qualification experience involving cloud platforms, servers, networks, or backup and recovery.\n\nExperience with Microsoft 365, SharePoint, Azure, Veeva, MasterControl, or comparable regulated platforms.\n\nDirect participation in an FDA or other health-authority inspection.\n\nFamiliarity with SOX IT general controls or SOC 2 readiness.\n\nExperience estimating engagements, mentoring colleagues, or leading validation programs.\n\nRelevant quality, validation, or IT audit credentials.\n\nSuccess in the first year\nAssigned clients have a documented system inventory, clear validation status, and agreed priorities for any gaps.\n\nValidation work is completed to an agreed scope and schedule, with clear documentation accepted through client QA review.\n\nPeriodic reviews, change assessments, and other assigned recurring activities are completed on schedule, with exceptions documented and escalated.\n\nAudit and inspection requests receive timely, accurate evidence and clear explanations.\n\nIdentified risks and findings have accountable owners, agreed actions, and tracked follow-through.\n\nReusable templates and delivery methods improve consistency without adding unnecessary documentation.\n\nDelivery effort is recorded accurately so leadership can plan capacity and price work appropriately.\n\nHow we work\nClient QA approves validation deliverables and GxP change decisions. We execute and recommend.\n\nApproval responsibilities are assigned to preserve appropriate independence. No one approves their own change.\n\nClient information remains confidential and separate from other clients' records.\n\nWork is assigned according to demonstrated competence, with specialist support and escalation when needed.\n\nWe favor clear, proportionate controls and defensible evidence that fit each client's regulated activities.\n\nvdB&A is an equal opportunity employer. We welcome and consider qualified applicants regardless of race, religion, gender identity, sexual orientation, disability, or any other status protected by applicable law.","description_format":"text","description_chars":7882,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Healthcare & Life Sciences Consulting","Accounting & Bookkeeping Services"],"lifecycle":[{"event":"open","at":"2026-10-15T22:08:21Z"}],"visa":[],"liveness":{"score":72,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.799,"p_room":0.9,"age_days":18,"expected_fill_days":33,"reasons":["conf:3","win:mid"],"computed_at":"2026-11-03T05:54:40Z"},"pay":null,"html_url":"https://alion.io/job/vandenboomassociates-gxp-it-validation-lead","json_url":"https://alion.io/job/vandenboomassociates-gxp-it-validation-lead.json","meta":{"generated_at":"2026-11-03T15:43:46Z","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 call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":21928,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-04T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":4600},"rest":"https://alion.io/mcp/rest/get_company?id=4600"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fvandenboomassociates-gxp-it-validation-lead"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fvandenboomassociates-gxp-it-validation-lead"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fvandenboomassociates-gxp-it-validation-lead"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/vandenboomassociates-gxp-it-validation-lead\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fvandenboomassociates-gxp-it-validation-lead"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2652316}},{"tool":"search_jobs","arguments":{"company":"vandenboomassociates.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2652316},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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