IT Quality & Regulatory Assurance Manager

Abbott

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Quick summary

Work type
On-site
Location
Waukegan, IL
Salary
$99,300–$198,700 / yr
Posted
1 day ago
Freshness
Confirmed live today

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Salary context

Competitive pay

How this pay compares to similar roles

Similar $163k
This role $149k
$87k most similar roles pay here $211k

This role pays less than 65% of similar roles. Most pay $135,437–$190,287 — the shaded band above. At the midpoint, this role pays about $149k versus about $163k for comparable roles.

Based on 240 similar postings.

Employer

About Abbott

Abbott Laboratories is a global healthcare company that manufactures and markets a broad and diversified line of health care products including diagnostics, medical devices, nutritionals, and branded generic pharmaceuticals. Industry: Healthcare & Medical Devices

Abbott currently has 87 open roles on FindRole.

Listed pay typically runs $99,300–$198,700 across 87 roles with salary data.

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At a glance

TL;DR · IT Quality & Regulatory Assurance Manager

The IT Quality & Regulatory Assurance Manager joins the Business Technology Services division to lead, manage, and coordinate operational activities within the IT Quality and Regulatory Assurance area. This role ensures compliance with global regulations and internal quality standards while minimizing impact on Global IT Organizations. Key responsibilities include providing oversight for the Software Life Cycle process, managing quality events and CAPA, maintaining quality system documentation, and ensuring audit and inspection readiness. The candidate will provide independent consultation to project teams and manage complex stakeholder relationships across Quality, Regulatory, and IT functions. Required expertise includes software development, validation, and regulated quality systems such as QMS, GxP, and CAPA. Preferred skills include knowledge of SaaS validation, AI types, and AI validation methods within the healthcare industry context to ensure compliant business outcomes for medical devices and pharmaceutical products.

What you'll do

  • Manage operational and administrative activities within the IT Quality and Regulatory Assurance area to ensure compliance with industry standards.
  • Provide quality oversight and guidance for the entire Software Life Cycle, including planning, development, validation, and maintenance.
  • Identify, investigate, and resolve nonconformities through root cause analysis and corrective and preventive actions (CAPA).
  • Develop, review, and maintain policies, procedures, and work instructions aligned with regulatory expectations.
  • Support internal and external audits by maintaining inspection readiness and managing audit responses.
  • Provide independent quality oversight and consultation to project teams and business stakeholders.
  • Use risk-based approaches to assess compliance impacts and recommend mitigation strategies for significant risks.
  • Manage direct reports, including performance monitoring, resource allocation, and professional development.

What we're looking for

  • Bachelor’s degree or equivalent experience.
  • 8+ years of combined experience in software development, validation, and/or regulated quality systems (QMS/GxP/CAPA).
  • 1-3 years of experience in a regulated software development or validation environment (QMS).
  • 1-3 years of experience in GxP quality systems for IT, Pharma, or Device.
  • Strong experience leading software validation efforts and providing quality system support to IT systems.
  • Knowledge of regulations and standards that affect the healthcare industry.
  • Effective communication and collaboration skills (preferred).
  • Knowledge of Software Lifecycle processes, AI types/validation methods, and SaaS validation (preferred).

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