Supply Chain Quality Manager - Operations
Listed on 2026-09-12
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Business
Regulatory Compliance Specialist
Supply Chain Quality Manager - Operations
Horsham, PA, USA
Job DescriptionPosted Tuesday, September 1, 2026 at 5:00 AM
About Signant Health:
At Signant Health, we help bring life-changing treatments to patients faster. We are a global evidence generation company that supports clinical trials with smart technology, scientific expertise, and hands‑on operational support — so better data leads to better decisions in healthcare. We embrace AI and advanced technologies to enhance every aspect of what we do, from data analysis to operational efficiency.
Our teams work at the intersection of science, technology, and patient experience, delivering digital solutions powered by AI innovation that make clinical trials more efficient, more accurate, and more accessible around the world. Trusted by leading pharmaceutical companies and CROs, our platforms and services support studies across more than 90 countries and have contributed to hundreds of new drug approvals.
If you are motivated by meaningful work, global impact, and innovation in clinical research and digital health — including the opportunity to work with cutting‑edge AI technologies — you will find purpose and opportunity at Signant Health.
About the Role
The Supply Chain Quality Manager is a senior individual contributor responsible for leading quality strategy and compliance across Signant Health's clinical supply chain for provisioned devices (phones, tablets), SIM cards, medical devices, and related accessories used in clinical trials. Reporting to the SVP Supply Chain and Supplies Operations and based on‑site in Horsham, PA , this role serves as the internal subject matter expert on transportation regulations, supplier and 3PL quality oversight, and device lifecycle standards.
You will partner with Supply Chain Operations and third‑party logistics vendors to drive quality outcomes across a global warehouse network — without direct reports — making independent quality judgments on transportation compliance, supplier performance, and device lifecycle standards that directly support the delivery of clinical trials worldwide.
Key Accountabilities
- Own the quality program for Signant Health's 3PL partners and device/hardware suppliers — conducting audits, managing performance scorecards, driving CAPA processes to closure, and developing and maintaining quality agreements with 3PL vendors performing supply chain operations on Signant Health's behalf.
- Serve as the internal SME on transportation regulations for clinical devices containing lithium batteries and for medical devices — covering IATA DGR, IMDG, 49 CFR (DOT/PHMSA), and UN 38.3 test requirements; review and approve shipping configurations, packaging specifications, and dangerous goods documentation across the global warehouse network.
- Partner with 3PL vendors to ensure packaging meets DOT/IATA specifications, shipping documents are accurate, and all courier coordination is compliant; evaluate and close transportation compliance gaps across US, UK, and other warehouse locations as the supply chain footprint evolves.
- Define, implement, and maintain quality standards across the entire device lifecycle — procurement and receiving, asset tagging, device configuration, SIM activation, deployment to clinical sites, returns processing, redeployment qualification, country‑specific regulatory certifications, and end‑of‑life disposal.
- Oversee quality controls for SIM card management including activation, project code assignment, multi‑protocol branch selection, deactivation at study closeout, and removal from returned devices.
- Collaborate with MDM and configuration teams to ensure device enrollment, software deployment, and retirement meet quality and regulatory standards across Android, iOS, and…
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