Sr. Data Governance & Quality Systems Lead

Philips•Plymouth, MN

6d•$129,000 - $205,000•Hybrid

About The Position

As the Sr. R&D Data Governance & QMS Manager, you will establish the data readiness, governance, and quality processes that serve as the foundation for scalable AI innovation, ensuring datasets, partnerships, and platforms are compliant, reusable, and ready to support growth across multiple programs worldwide. Your role: Establish and improve the IGT Devices R&D data-governance and QMS framework for software, AI, hardware-generated, and experimental data. Define common standards, decision rights, federated stewardship, metadata, lineage, and quality. Lead the governance and QMS workstream for hospitals, research-sites, vendors, and cross-business-unit data arrangements through controlled release. With clinical and partnership leads and Legal, Privacy, Quality, Security, and Procurement, define intended use, data rights, residency, cross-border constraints, controls, approvals, and obligations. Embed approved requirements in data intake and processing through de-identification, access, data contracts, metadata, lineage, quality checks, release gates, regional or federated processing, retention, and deletion. Enable compliant reuse for software and AI. Operate stewardship, training, metrics, controlled documentation, and audit readiness; coordinating evidence, remediation, and continuous improvement for audits and medical-device inspections.

Requirements

5+ years of experience with a bachelor's degree (or 3+ years with a master's degree) leading data governance and QMS processes in medical devices, healthcare, life sciences, or another regulated environment, including federated stewardship, controlled documentation, training, and audit/inspection readiness.
Strong understanding and application of HIPAA and GDPR, including data residency, localization, cross-border transfer, regional processing, de-identification or anonymization, and re-identification risk.
Expertise leading dataset-level privacy-risk assessments and translating findings into documented release decisions, permitted uses, and technical controls.
Ability to translate governance and QMS requirements into technical controls and audit evidence; experience with AI/ML data governance required.
Bachelor’s or master’s degree in data management, informatics, engineering, computer science, quality, regulatory, privacy, or a related field or 9+ years of related experience in lieu of a degree.
Effective communicator with strong written and verbal skills and a demonstrated ability to influence and align stakeholders across functions without direct authority.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Nice To Haves

AI governance or risk management experience preferred.
HITRUST de-identification training or CIPP, CIPM, CIPT, CDMP, CRISC, or ISO/IEC 27559 certifications are a plus.

Responsibilities

Establish and improve the IGT Devices R&D data-governance and QMS framework for software, AI, hardware-generated, and experimental data. Define common standards, decision rights, federated stewardship, metadata, lineage, and quality.
Lead the governance and QMS workstream for hospitals, research-sites, vendors, and cross-business-unit data arrangements through controlled release. With clinical and partnership leads and Legal, Privacy, Quality, Security, and Procurement, define intended use, data rights, residency, cross-border constraints, controls, approvals, and obligations.
Embed approved requirements in data intake and processing through de-identification, access, data contracts, metadata, lineage, quality checks, release gates, regional or federated processing, retention, and deletion. Enable compliant reuse for software and AI.
Operate stewardship, training, metrics, controlled documentation, and audit readiness; coordinating evidence, remediation, and continuous improvement for audits and medical-device inspections.