IT Quality & Regulatory Assurance Manager

Abbott Laboratories; Waukegan (IL); On-site; USD 99,000 - 199,000; Full time

Job summary

Abbott Laboratories in Illinois seeks an experienced leader to oversee IT Quality and Regulatory Assurance activities, ensuring global regulatory compliance while minimizing impact on IT operations.

You will drive Software Life Cycle governance, CAPA, audits, risk management, and quality system documentation across projects, partnering with Quality, Regulatory, IT, and business teams.

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

• Lead SLC governance and ensure compliance with regulatory requirements across IT projects.
• oversee CAPA processes, including root cause analysis and verification of effectiveness.
• Develop and maintain quality system documentation and audits readiness.
• Provide independent quality oversight and partner with business stakeholders on risk and compliance decisions.

Skills

Quality assurance

Regulatory knowledge

Software validation

Leadership

Communication skills

Risk management

Stakeholder management

Education

Bachelor’s degree or equivalent experience

Tools

QMS

GxP

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.

JOB DESCRIPTION:

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. 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

• 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.

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.

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.

JOB FAMILY: Information Risk & Quality Assurance DIVISION: BTS Business Technology Services LOCATION: United States > Waukegan : J46 ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential - because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions - across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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