Supply Chain Quality Manager - Operations
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 Windows platforms; ensure medical device quality standards are maintained across sourcing and redeployment workflows.
Maintain Signant Health's supply chain QMS in alignment with ISO 13485:2016 (incorporated into FDA QMSR / 21 CFR Part 820), EU MDR, and UK HSE requirements; monitor evolving regulations across consumer electronics (FCC, CE, WEEE/e-waste) and medical devices and proactively update internal policies, SOPs, and quality agreements.
Ensure Good Documentation Practices are consistently applied across configuration records, picking slips, quality check logs, and deviation documentation; support internal audits, regulatory inspections, and customer quality reviews as the supply chain quality SME.
Develop quality KPIs and dashboards covering supplier performance, transportation compliance, device lifecycle quality, and 3PL adherence; lead root cause analysis in collaboration with Supply Chain Operations.
Lead continuous improvement initiatives across warehouse operations and 3PL partners; represent the quality function in cross-functional programs including new clinical study device launches, carrier integrations, warehouse model changes, and supply chain transformation initiatives.
Knowledge, Skills & Attributes
Essential:
Bachelor's degree in Supply Chain Management, Engineering, Quality Management, Biomedical Engineering, or a related field; 6–9 years of progressive experience in supply chain quality, logistics compliance, or device operations, ideally within clinical trials, life sciences, telecom, or consumer electronics.
Working knowledge of lithium battery transport regulations: IATA DGR, IMDG, 49 CFR/PHMSA, and UN 38.3.
Solid understanding of ISO 13485:2016 / FDA QMSR (21 CFR Part 820) and EU MDR as they apply to supply chain and distribution operations.
Experience designing and executing 3PL quality agreements, audits, and performance management programs.
Familiarity with device lifecycle management in a clinical or enterprise context, from procurement through end-of-life.
Proven ability to influence cross-functional stakeholders and drive quality outcomes without direct organizational authority.
Experience with inventory management systems and Good Documentation Practices.
Strong analytical skills with experience building KPI frameworks and quality reporting for leadership; experience applying structured problem-solving methodologies such as DMAIC, root cause analysis, or Lean Six Sigma.
Experience leading cross-functional change initiatives and driving continuous improvement in regulated environments.
Ability to utilize Company-issued and approved Artificial Intelligence (AI) tools to support productivity, efficiency, and quality of work, while maintaining accountability for all AI-generated outputs.
Desirable:
ASQ Certified Quality Engineer (CQE) or Certified Manager of Quality/Organizational Excellence (CMQ/OE).
ISO 13485 internal auditor certification.
Lean Six Sigma Green Belt certification.
IATA CEIV Lithium Battery certification or completion of the IATA Lithium Battery Logistics Safety Management course.
APICS CPIM or CSCP.