Quality Systems and Compliance Lead

Responsibilities

Leads the ongoing vision and implementation of the Quality Management System (QMS) — spanning consumer, research, and medical device (SaMD) quality, including AI/ML-enabled and generative AI products — in conformance with domestic and international GMP, GCP, GCLP, and GLP regulatory requirements and industry best practices applicable to the portfolio of products and services supported.

Leads strategic and tactical Quality Planning activities with cross-functional stakeholders across Verily's medical device, research, and commercial programs, including Software as a Medical Device (SaMD), AI/ML and generative AI applications, consumer health, and medical research contexts, ensuring quality frameworks are fit-for-purpose across each domain.

Develops and advances quality oversight frameworks for AI/ML and generative AI products, including considerations for model validation, monitoring, algorithmic change protocols, and alignment with emerging regulatory guidance (e.g., FDA's AI/ML-based SaMD action plan, predetermined change control plans).

Maintains and advances ISO 13485:2016 certification across Verily's QMS; leads expansion to additional certifications (e.g., MDSAP) as directed by business objectives, in accordance with QA domain responsibilities.

Analyzes quality metrics and performance data across consumer, medical research, SaMD, and AI/ML programs to identify trends, drive continuous improvement, and implement effective corrective and preventive actions (CAPA).

Staffs and develops their QA team with the skills and experience to support quality domains spanning consumer, research, regulated medical device, and AI/ML programs; balances business needs with regulatory compliance.

Fosters a culture of organizational compliance to the QMS through ongoing GxP training, education, and quality awareness initiatives across all product domains, including emerging practices for AI/ML and generative AI governance.

Partners with engineering and product teams to embed quality practices into software development workflows; experience with Jira and GitHub (or equivalent tools) is a plus for supporting SaMD and AI/ML quality processes including change control, issue tracking, and Design and Development File management per ISO 13485:2016.

Qualifications

• Bachelor's degree in a scientific, engineering, or related field with 8+ years of experience in quality assurance or regulatory affairs within the medical device, digital health, or life sciences industry.
• Demonstrated experience leading or managing a QMS in conformance with ISO 13485:2016 and FDA QMSR across multiple product domains, including hands-on experience with design and development, CAPA, risk management processes per ISO 14971 and medical device software lifecycle processes per IEC 62304.
• Experience supporting or managing quality across SaMD and/or AI/ML-enabled products, with working knowledge of applicable FDA guidance and international regulatory frameworks.
• Proven ability to lead cross-functional quality initiatives, manage and develop QA teams, and influence stakeholders across engineering, product, and clinical organizations.