Sr. Manager - Global Software Quality at Abbott Laboratories

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.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and 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 .

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• An excellent retirement savings plan with 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

The Sr. Manager - Global Software Quality works out of our Lake Forest, IL location in the Cardiometabolic and Informatics Division of Abbott Rapid Diagnostics. Our diagnostic solutions are used in hospitals, laboratories and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. This role is on site

What You’ll Work On

• Ensure Global Compliance: You’ll be responsible for making sure our IT policies and procedures meet global quality and documentation standards, and comply with regulations.

• Analyze and Solve Problems: Conduct trend analysis to identify and fix systemic issues, working closely with stakeholders.

• Oversee IT Systems: Manage software and IT systems, including development and change control processes for applications and infrastructure.

• Lead Improvements: Drive continuous improvement activities using project management skills, and lead software validation and quality assurance efforts.

• Develop Programs: Create, maintain, and oversee the divisional software development and validation program.

• Train Staff: Develop and conduct training sessions for company personnel on software development and validation.

• Collaborate with Engineering: Work with Design and Manufacturing Engineering teams to complete system/software requirements and validation processes.

• Manage Code Control: Implement solutions for code control and administer software event/defect tracking systems.

• Risk Analysis: Assist in completing and maintaining risk analysis, focusing on software-related risks.

• Improve Processes: Design and implement product and process improvement methodologies like Six Sigma and Lean Manufacturing.

• Manage Budget: Develop and manage the department’s operating budget.

• Support Initiatives: Support divisional initiatives related to Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

• Hire and Retain Staff: Hire and retain a diverse, highly qualified team, providing ongoing performance feedback and maintaining a safe, professional work environment.

• Ensure Compliance: Comply with FDA regulations, other regulatory requirements, company policies, and operating procedures.

• Foster Collaboration: Maintain positive and cooperative communication and collaboration with employees, customers, contractors, and vendors.

QUALIFICATIONS

• Bachelor’s Degree in Engineering, preferably Manufacturing or Mechanical Engineering, and 7 years of related work experience IT or SW Validation is required in quality and regulated environment

• International travel: UK, Scandinavia, and possibly other country areas up to 10%

Preferred Qualifications

The below items are ideal for the candidate to already have experience with at this job level:

• Regulatory CAPA, Training, Documentation, Validation, 21 CFR Part 11, Supplier Management, Audit, and Management Reporting requirements

• IT systems and development and change control processes, including applications and infrastructure processes and controls

• Experience leading compliance with regulations and industry standards (21 FDA CFR Part 820, ISO 13485, and ISO 14971) in a highly regulated software development/validation environment

• Hands on with GxP quality systems for IT, Pharmaceutical, or Medical Device industries.

• Advanced Experience with Root Cause Analysis

• Demonstrated experience with data driven decision making skills

• Global Operation experience

• Advanced knowledge of MS-Office Suite

• Strong financial acumen

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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 and @AbbottGlobal.

The base pay for this position is $125,300.00 – $250,700.00. In specific locations, the pay range may vary from the range posted.