Senior IT Quality & Regulatory Assurance Manager

Senior It Quality & Regulatory Assurance Manager

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

The Opportunity : As a Senior IT Quality & Regulatory Assurance Manager, you will lead SQA for US-based programs (e.g., Digital, Complaint Management, Salesforce). As the Process Owner of the BTS Software Lifecycle, you ensure the applicable regulatory requirements are incorporated, oversee the execution to those requirements, and monitor the effectivity with consideration to evolving technologies, platforms, and compliance.

Partners with vendors to ensure reliable, compliant, and cost-effective SQA support is provided for operations and audit support, while scaling for programs and initiatives. Provides the US-based SQA leads with direction and resources to enable compliance and effective program delivery, support, and inspection readiness.

Position Accountability / Scope : The role reports to the Director, BTS Global Software Quality Assurance within Quality, Regulatory & Compliance organization. The role works with the senior levels of the BTS IT organization as well as leaders across Abbott's Quality Organization to drive improvements in BTS SQA Operations. The role works closely with peers and lower levels of BTS IT to sustain a quality mindset within the IT organization.

Position is accountable for all phases of the SLC activities and works directly with BTS IT, Divisional Quality and relevant Process Owners. Provides quality guidance to less experienced staff. Act as a mentor and provide guidance to junior team members and individual contributors. Make decisions and take actions that significantly influence business success. Understand that failure to achieve results or making incorrect decisions / recommendations can lead to serious program delays, audit findings, and substantial resource expenditures.

What You'll Work On : Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Understands corporation's vision, goals and strategies. Determines critical success factors, evaluates and pursues initiatives, investments and opportunities based on fit with strategies. Champion change and innovation, while stimulating creativity and innovation in others. Responsible for setting goals, performance assessments and supporting the development of growth plans of employees. Responsible for implementing and maintaining the effectiveness of compliance system at a global level. Manages the analysis, development and implementation of metrics for assessing quality software processes and systems. Represents division on cross divisional process improvement initiatives.

Required Qualifications & Education : Bachelor's degree in computer science, Information Technology or equivalent. Minimum Experience Required : 10-15 years of related work experience with IT Quality in the life science industry, or an equivalent combination of education and work experience. Strong leadership experience managing resources, global IT Programs, or / and related functions. Experience introducing emerging technologies, like AI, and provide strategic recommendations. Ensure all applicable regulatory requirements are integrated into processes and oversee execution to maintain compliance. Continuously monitor effectiveness while adapting to evolving technologies, platforms, and compliance standards.

Preferred Qualifications : Certifications from ASQ and ISO9001 or ISO13485 preferred. Supervisory / Management Responsibilities : 5 Direct reports and multiple indirect reports.

This is an on-site role and NOT a remote role.