IT Quality & Regulatory Assurance Manager

Information Technology Senior Management Forum; Waukegan (IL); On-site; USD 99,000 - 199,000; Full time

Benefits offered by this job

Onsite role in IL

Health benefits

Retirement plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott is a global healthcare leader with operations spanning diagnostics, medical devices, nutritionals, and branded medicines. The Opportunity focuses on leading IT Quality and Regulatory Assurance activities to achieve regulatory compliance while minimizing impact on Global IT.

This onsite role supports governance of the Abbott Software Life Cycle and quality systems, including CAPA, documentation, audits, and risk management.

Qualifications

• 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.

Responsibilities

• Serve as a subject matter expert for the Abbott Software Life Cycle process and provide quality oversight.
• Ensure compliance with applicable regulatory requirements and internal quality standards.
• Develop and deliver 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.
• Provide independent quality oversight, direction, and consultation to project teams, system owners, and business stakeholders.

Skills

Software validation

Quality assurance

Regulated quality systems

GxP knowledge

Regulatory compliance

Education

Bachelor’s degree or equivalent experience

Job description

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 122,000 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 forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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. This role is not within the software testing organization.

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

Software Life Cycle (SLC) Governance

• 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 Management / CAPA

• 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.

Quality System Documentation

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

Audit and Inspection Readiness

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

Quality Oversight and Business Partnership

• 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.

Risk Management and Compliance Decision Making

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

Stakeholder, Relationship, and Escalation Management

• 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.

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/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.

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.
• Responsibility for performance monitoring and resource allocation.
• 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.

• 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 $99,300.00 – $198,700.00. In specific locations, the pay range may vary from the range posted.