Sr. Manager, Digital Quality Excellence

Accountabilities • Define and execute the enterprise Digital Quality Excellence strategy, roadmap, governance model, and capabilities.

• Ensure digital quality systems, analytics solutions, and data practices align with applicable regulatory and quality requirements.

• Partner with IT, Regulatory Affairs, Quality, and business stakeholders to embed quality requirements into digital platforms, data architecture, and system implementations.

• Establish governance for AI and digital quality systems, including validation, data integrity, algorithm monitoring, change control, and regulatory compliance.

• Provide strategic and technical leadership for enterprise digital quality initiatives and ensure alignment with QMS governance and business priorities.

• Drive digital transformation through automation, analytics, AI, Lean principles, and operational excellence initiatives.

• Measure the impact of digital quality investments on operational performance, quality outcomes, user experience, productivity, and cost efficiency.

• Lead change management, stakeholder engagement, and organizational capability development to drive sustainable adoption of new digital capabilities.

• Establish and advance quality intelligence capabilities supporting proactive risk identification, predictive monitoring, data-driven decisions, and regulatory readiness.

• Ensure quality data, digital systems, and analytics outputs are accurate, reliable, and audit-ready for inspections and regulatory reviews.

• Develop enterprise governance frameworks and strategies for AI-enabled medical technologies and Software as a Medical Device (SaMD).

• Advise senior leadership on emerging AI technologies, opportunities, risks, and regulatory developments.

• Partner with product development teams to ensure AI-enabled products are developed and maintained in accordance with applicable quality and regulatory requirements.

• Interpret emerging global AI and SaMD regulations and standards and translate them into practical quality and product-development practices.

• Assess the impact of evolving regulations and standards on product development, quality systems, and enterprise operations.

• Lead and develop teams while managing complex, cross-functional initiatives across a global organization.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, Data Science, or a related technical discipline; an advanced degree is preferred.

• At least 8 years of experience in Quality Systems, Quality Engineering, Digital Quality, Analytics, or related functions within a regulated industry such as medical devices, pharmaceuticals, or biotechnology.

• At least 5 years of leadership experience managing teams and enterprise-level initiatives.

• Strong knowledge of global Quality Management System requirements, including FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 9001, and EU MDR.

• Experience implementing digital quality systems, analytics platforms, dashboards, or enterprise data solutions.

• Experience leading cross-functional initiatives involving Quality, IT, Regulatory Affairs, and business stakeholders.

• Experience with AI, machine learning, advanced analytics, or digital health technologies in regulated environments.

• Strong understanding of QMS processes such as complaints, CAPA, audits, and management review.

• Demonstrated ability to develop enterprise analytics, dashboards, and data-driven performance management frameworks.

• Knowledge of digital technologies, data governance, system integrations, and enterprise data architecture.

• Hands-on experience implementing and scaling digital, AI, or data-driven solutions within regulated Quality environments.

• Experience applying Computer System Validation (CSV) and/or Computer Software Assurance (CSA) principles.

• Understanding of machine learning development lifecycles, including model training, testing, validation, and monitoring.

• Knowledge of algorithm drift, bias mitigation, explainability, and model governance.

• Ability to evaluate AI development methodologies and quality controls and translate evolving AI regulations into actionable practices.

• Experience developing enterprise governance frameworks and operating models.

• Strong strategic thinking, leadership, organizational, problem-solving, and decision-making capabilities.

• Ability to influence senior leadership and drive enterprise-wide change and adoption.

• Excellent written and verbal communication skills.

• Ability to manage multiple priorities in a complex, global environment.

• Proficiency with analytics and reporting platforms such as Power BI, Tableau, or similar tools is preferred.

• RAC, ASQ CSQE, or software quality certifications are preferred.

Benefits

• Base salary ranging from $178,000 to $215,000 , plus an annual bonus opportunity of 25% .

• Health, dental, and vision insurance.

• 401(k) plan with company match.

• Paid time off.

• Wellness initiatives and health assistance resources.

• Life insurance.

• Short- and long-term disability benefits.

• Health and dependent care flexible spending accounts.

• Commuter benefits.

• Parental and caregiver leave.

• Tuition reimbursement.

• Remote work opportunity in the United States.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether?

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