Jobs / United States / Novartis Pharmaceuticals Corporation
TRD QA Specialist
Novartis Pharmaceuticals Corporation · 🇺🇸 Ivrea
Sponsorship verdict
Sponsorship possible
One solid signal, not two — worth applying, and worth asking about sponsorship early.
- Employer is on a government sponsor recordThe US Department of Labor certified 75 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 31 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
- The posting doesn’t mention sponsorshipSilence isn’t a refusal — ask the recruiter before investing much time.
- No salary bar for this routeH-1B has no fixed salary bar: the employer must pay at least the prevailing wage for the role and area. Cap-subject employers enter a lottery weighted by wage level. Source: https://www.federalregister.gov/documents/2025/12/29/2025-23853/weighted-selection-process-for-registrants-and-petitioners-seeking-to-file-cap-subject-h-1b, rules effective 2026-02-27.
- Confirmed live todayWhen a source last listed this job as open.
US H-1B: cap-subject employers enter a lottery weighted by wage level — Level I gets 1 entry, Level IV gets 4 (DHS projected selection odds ≈15% at Level I to ≈61% at Level IV). Universities and non-profit research employers are cap-exempt. The $100,000 fee for new petitions from abroad is currently blocked by a court order (appeal pending).
A verdict summarises public evidence; it is not legal advice and never a guarantee — the employer and the immigration authority decide. Sign in to factor in where you can already work.
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Sponsor Radar — Novartis Pharmaceuticals Corporation
The US Department of Labor certified 75 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 31 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
Past sponsorship or register membership never guarantees sponsorship for this vacancy or for you. Full Sponsor Radar for Novartis Pharmaceuticals Corporation →
About the role
Salary Range: €29,800.00 - €55,300.00 Job Description Summary Location: Ivrea, Italy #onsite Role Purpose: During the Pilot Plant ramp-up and operationalization, provide QA oversight and support for the establishment of a compliant quality system for GMP-relevant IT, OT, computerized, and automated systems. The role focuses on system qualification and validation, data integrity, lifecycle documentation, procedures, interfaces, equipment connectivity, and ongoing compliance. The QA Specialist will support the implementation and qualification of computerized systems used in manufacturing, QC laboratories, facilities, utilities, and supply-chain processes. In routine operations, the role ensures that these systems remain compliant, fit for intended use, and maintained in a validated state throughout their lifecycle. Hiring a QA Specialist with IT/OT expertise for the TRD RLT Colleretto Giacosa Pilot Plant is essential to establish local Quality capability for IT/OT system qualification, procedure development, and initial manufacturing-line validation. The role requires hands-on experience with computerized systems in pharmaceutical or regulated environments, strong knowledge of quality assurance and data-integrity principles, and effective collaboration with all the stakeholders. Job Description Major Accountabilities • Act as the local QA subject-matter expert for GMP-relevant IT/OT systems, providing independent quality oversight while supporting cross-functional execution during project ramp-up. • Review and approve key validation and qualification deliverables, including User Requirements Specifications, risk assessments, validation plans, test protocols, executed test evidence, deviations, and qualification or validation summary reports. • Ensure that global applications, locally configured systems, infrastructure components, equipment software, interfaces, and data flows are appropriately assessed, qualified, and released before GMP use. • Ensure clear definition of responsibilities among system owners, system users, IT, OT, Engineering, Quality, and support functions throughout the system lifecycle. • Ensure implementation and QA oversight of controls related to user access, audit trails, electronic records, electronic signatures, backup, restoration, archiving, business continuity, system security, and data integrity. • Review and approve changes, deviations, CAPAs, and risk assessments affecting GMP-relevant computerized systems. • Coordinate and support periodic reviews to confirm that computerized systems remain compliant, supported, secure, fit for intended use, and in a validated state. • Support the drafting, review, approval, and maintenance of GxP procedures governing computerized-system validation, system administration, access management, audit-trail review, backup and restore, incident management, change control, periodic review, and system retirement. • Support internal audits and Health Authority inspections involving computerized systems, data integrity, automation, electronic records, and electronic signatures. • Contribute to continuous improvement initiatives, including optimization of validation activities and implementation of risk-based quality practices aligned with the operational maturity of the Pilot Plant. Key Performance Indicators • Timely qualification and release of GMP-relevant IT/OT and computerized systems in line with approved quality standards and project timelines. • Timely completion of validation deliverables, periodic reviews, deviations, CAPAs, changes, and access reviews. • Positive outcomes from internal audits and external inspections, with no critical compliance gaps attributable to QA oversight of IT/OT systems. • Consistent role modelling of Novartis culture