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 115,000 colleagues serve people in more than 160 countries.

Working at Abbott

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.
  
  

The Opportunity  

Lead, manage, plan, and coordinate operational and administrative activities within the IT Quality and Regulatory Assurance area to achieve compliance with regulations and industry standards, while minimizing impact on Global IT Organizations.

Accountable for global compliance to Abbott policies and procedures that have specific applicability in quality, including documentation and adherence to global regulations.

What You’ll Work On

• 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.
  
  

Minimum Requirements & Qualifications :

Minimum Qualifications :

• 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.
  
  

Preferred Qualifications :

• 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
  
  

Supervisory Responsibilities

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

Misc : This is an onsite role at Abbott location in IL This is not a remote role/opportunity.

Apply Now

• Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives : www.abbottbenefits.com
• Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
• Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.
  
  

The base pay for this position is $113,300.00 – $226,700.00. In specific locations, the pay range may vary from the range posted.