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.

• Serves as a source of information to IT organizations on the compliance needs and regulatory environment.
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
•  Responsible for the interpretation and communication of systems compliance regulations.
• Responsible for the analysis, development and implementation of metrics for assessing quality software processes and systems.
• Provides leadership to maintain compliance and consistency. 
• Understands organization's vision, goals and strategies.
• Stimulates creativity and innovation in others.
• Manage associated budget responsibilities, including meeting expenses, recovery, and forecast plans; continually looking for opportunities for cost avoidance and cost reductions.
• Represents Software Quality Assurance on cross divisional process improvement     initiatives.
• Ensures appropriate, consistent, and good communications at all management levels.
• Participates in setting policies and procedures.
• Establishes and maintains productive relationships with all levels in Abbott IT organization and with external partners.
• Aligns with and influences our external partners in support of divisional and corporate IT strategies.
• Operates within broad goals and objectives.
• Makes strategic decisions that impact division/sites and/or influence global organizations.
• Responsible for implementing and maintaining the effectiveness of compliance at a division level.
• Actively addresses employee issues in a constructive and timely manner.
• Responsible for team morale and promotes cohesive attitude.
• Responsible for conformance and adherence of policy, process and procedure documentation in accordance with Abbott's quality system.
   

• Bachelor’s degree or equivalent experience
• 8+ years combined experience in software development, validation, and/or regulated quality systems (QMS).
• 1-3 years’ experience in a regulated software development / validation environment.
• 1-3 years’ experience in leading software validation efforts, providing software quality assurance support, providing quality system support to IT systems.
• 1-3 years’ experience in GxP quality systems for IT, Pharma, or Device.
• 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.
• →May have responsibility for setting goals, performance assessments and developing growth plan for direct reports.