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Job description
Job Description
Join Global Quality Management Systems as the Director, Head of Digital Quality & Intelligence, a high-impact leadership role at the intersection of quality, data, automation, AI, and digital transformation. This leader will shape and advance the quality intelligence strategy for Global Quality and Global Regulatory Affairs, translating business and regulatory needs into scalable insights, modern digital capabilities, and measurable outcomes.
Overview
The Director, Head of Digital Quality & Intelligence, within Global Quality Management Systems (QMS), provides strategic leadership for quality intelligence, analytics, automation, AI enablement, eQMS support, and QMS modernization roadmap execution across Global Quality (GQ) and Global Regulatory Affairs (GRA).Reporting to the AVP of QMS, this role leads a global team of data analysts, data scientists, and software developers to translate quality, regulatory, and business needs into actionable insights, scalable digital capabilities, and measurable business outcomes while ensuring responsible, controlled use of data, AI, and automation.
Overall Responsibilities
Develop and manage an integrated, risk-based QMS strategy, portfolio, and roadmap for GQ and GRA, covering analytics, automation, AI, eQMS support, and QMS modernization priorities.
Partner with global stakeholders to translate complex quality, regulatory, and business problems into data-driven, automated, and scalable digital solutions.
Establish governance, infrastructure, lifecycle controls, and delivery practices for analytics, automation, AI, and eQMS capabilities from concept through validation, release, adoption, and support.
Lead portfolio, program, and project management across AI, eQMS, process harmonization, and quality roadmap initiatives, including prioritization, resource planning, dependencies, risk management, executive reporting, and benefits realization.
Apply strong QMS expertise to align digital quality initiatives with global process architecture, regulatory expectations, inspection readiness, risk-based decision-making, and business outcomes.
Champion adoption and change leadership by influencing senior leaders, addressing resistance, and translating technical concepts into clear quality and business value.
Ensure responsible and compliant use of AI, automation, analytics, and digital quality tools through appropriate data governance, model oversight, computer system validation considerations, and audit readiness controls.
Monitor industry, digital, AI, automation, and quality trends to identify opportunities, anticipate business needs, and strengthen GQ capabilities.
Serve as a strategic thought partner to the VP of Quality and GQ leadership on complex problems, data science applications, automation opportunities, and future quality strategies.
Team Leadership
Direct and manage the global Digital Quality & Intelligence team, building advanced analytics, automation, AI enablement, and quality intelligence as core GQ capabilities.
Lead talent management, organizational design, performance management, technical capability development, and leadership development for the global Digital Quality & Intelligence team.
Advance team capability through cross-sector rotations, assignments, collaborations, and adoption of best practices.
Qualifications
Bachelor's degree in computer science, mathematics, statistics, data science, engineering, life sciences, or a related quantitative/scientific field is required; advanced degree strongly preferred.
10+ years of industry experience with increasing managerial responsibility and matrix leadership in a life science environment, such as medical device, diagnostics, biopharma, or pharmaceutical spaces.
5+ years managing diverse, global teams, including 3+ years leading analytics, automation, AI, digital quality, or related technology-enabled quality capabilities.
Demonstrated experience within or leading QMS functions, including global processes, process harmonization, regulated quality operations, inspection readiness, governance, and continuous improvement.
Proven portfolio, program, and project management experience across complex cross-functional initiatives, preferably including eQMS implementation, digital quality transformation, enterprise roadmap execution, resource planning, governance, and executive reporting.
Experience leading teams that work with structured and unstructured quality, regulatory, manufacturing, customer feedback, and product quality data.
Working knowledge of analytics platforms, data architecture, cloud environments, code management, version control, and modern development practices, with the ability to guide technical teams and make sound design and prioritization decisions.
Essential Skills
Strong QMS acumen, with the ability to connect digital, analytics, automation, AI, and eQMS capabilities to global quality processes, regulatory expectations, risk management, and business outcomes. Advanced po
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Worksite address
santa clara, CA, 95053, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.