Senior Manager, IT QA - Regulatory Assurance

What you'll do

• Oversee IT Quality Assurance activities to ensure compliance with regulatory requirements and corporate standards.
• Lead, mentor, and develop a high-performing team of managers and engineers.
• Design and implement automation solutions and digital tools to streamline Software Lifecycle activities.
• Architect validation strategies and policy frameworks to harmonize quality processes across the enterprise.
• Manage audit defense, inspection responses, and the execution of Corrective Action and Preventive Action (CAPA) plans.
• Oversee vendor management, contract performance, and compliance with service level agreements.
• Monitor IT system health and risk using advanced metrics, KPIs, and data-driven dashboards.
• Identify opportunities for process automation to improve efficiency and ensure audit readiness.

What we're looking for

• Bachelor's Degree with 8 years’ experience, Master's with 7 years, or PhD with 3 years.
• Experience in SQA, CSV, investigations, and/or auditing.
• At least 2 years of experience in a formal people management and supervisory capacity leading quality professionals and managers.
• Expertise in regulatory assurance, process improvement, enterprise risk management, automation, validation strategy, and audit responses.
• Ability to develop and execute policy frameworks, validation strategies, and process harmonization at the enterprise level.
• Advanced knowledge of cloud, automated testing, AI/ML applications, advanced quality analytics, and Computer Software Assurance (CSA) practices.
• Experience managing cross-functional teams, vendor relationships, contract management, resource allocation, and budgeting.
• ASQ Certified Quality Auditor, PMP, Six Sigma, or equivalent certifications (preferred).