IT Quality & Regulatory Assurance Manager

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

• Serve as a subject matter expert for the Abbott Software Life Cycle process.
• Provide quality oversight and guidance throughout system planning, development, validation, implementation, maintenance, and retirement activities.
• Ensure compliance with applicable regulatory requirements and internal quality standards.
• Support development and delivery of SLC training and awareness initiatives.
• Promote a culture of quality, compliance, accountability, and continuous improvement
• Identify opportunities to improve compliance processes, quality system effectiveness, and operational efficiency.

• Quality event identification, assessment, investigation, documentation, and resolution for suspected policy, process, procedure, or system nonconformities.
• Ensure effective root cause analysis, corrective and preventive actions (CAPA), and verification of effectiveness.

• Development, review, approval, and maintenance of policies, processes, procedures, standards, and work instructions in alignment with Abbott Quality System requirements and regulatory expectations.

• Support internal audits, external audits, supplier audits, and regulatory inspections.
• Maintain inspection readiness through effective quality system monitoring, audit response management, and remediation activities.

• Provide independent quality oversight, direction, and consultation to project teams, system owners, and business stakeholders.
• Ensure business objectives, risk management considerations, and quality requirements are appropriately balanced and aligned.

• Utilize risk-based approaches to assess compliance impacts and support informed business decisions.
• Escalate significant compliance risks and recommend appropriate mitigation strategies.

• Build effective partnerships across Quality, Regulatory, IT, and Business functions.
• Manage complex stakeholder relationships and provide leadership through issue resolution and escalation processes.
• Influence decision-making at multiple organizational levels to achieve compliant business outcomes.

• Bachelor’s degree or equivalent experience
• 8+ years combined experience in software development, validation, and/or regulated quality systems (QMS/GxP/CAPA).
• 1-3 years’ experience in a regulated software development / validation environment (QMS)
• 1-3 years’ experience in GxP quality systems for IT, Pharma, or Device.
• Strong experience in leading software validation efforts, providing software quality assurance support, providing quality system support to IT systems.
• Knowledge of regulations and standards that affect the health care industry.

• Effective communication skills and collaboration skills.
• Knowledge of Software Lifecycle and software methodologies (SLC processes).
• Knowledge of AI types and AI validation methods.
• Knowledge of SaaS validation and compliance

• →Has direct/indirect reports.
• →Responsibility for performance monitoring and resource allocation. 
• →May have responsibility for setting goals, performance assessments and developing growth plan for direct reports.