Jobs / United States / Novartis Pharmaceuticals Corporation
Manufacturing Quality Assurance Specialist
Novartis Pharmaceuticals Corporation · 🇺🇸 Durham
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
Job Description Summary Quality is not just a checkpoint here—it is the promise we make to patients. As a Manufacturing Quality Assurance Specialist at Novartis, you will be a hands-on partner to manufacturing teams, ensuring every stage of production meets the highest standards of quality, compliance, and scientific rigor. From shop floor presence to final product release, your expertise will directly influence patient safety and product integrity while helping drive continuous improvement in a fast-paced, purpose-driven manufacturing environment. Job Description Location: • This position will be located in Durham, NC and will be an onsite role. • Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Shift: • This will be a third shift role working 11:00 pm - 7:30 am, Monday - Friday Key Responsibilities: • Provide proactive quality oversight through shop floor presence, walkthroughs, and real-time manufacturing support. • Review and approve master and executed batch records to ensure compliant clinical and commercial production. • Partner with manufacturing teams to ensure consistent, compliant processes aligned with GMP requirements. • Support media, buffer, cell expansion, upstream, downstream, and aseptic filling manufacturing operations. • Lead deviation and corrective action investigations, ensuring thorough root cause analysis and effective remediation. • Review alarms, data integrity, and electronic records to confirm accuracy and regulatory compliance. • Support internal and external audits, inspections, and regulatory readiness activities. • Provide quality expertise in manufacturing batch record design, review, and continuous improvement. • Analyze quality metrics, identify trends, and communicate actionable insights to management. • Lead or contribute to continuous improvement and quality system enhancement projects. Essential Requirements: • Bachelor of Science degree in microbiology, chemistry, biochemistry, or a related scientific discipline. • Minimum of five years of experience working in a regulated GMP manufacturing environment. • Strong working knowledge and application of CFR, FDA, and EU regulatory requirements. • Proven experience supporting or participating in FDA and EU regulatory inspections and audits. • Hands-on experience reviewing, authoring, and approving quality procedures and standard operating documents. • Demonstrated ability to manage deviations, investigations, and corrective and preventive actions to closure. • Strong analytical skills with the ability to interpret data, identify trends, and recommend compliant paths forward. • Excellent written and verbal communication skills with the ability to collaborate effectively across functions. Desirable Requirements: • Experience supporting viral gene therapies or orphan disease manufacturing programs. • Experience leading or coordinating internal quality audits and inspection readiness activities. Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $43.08 and $80.00 per hour. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, emp