Global IT Quality & Regulatory Assurance Lead

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

Benefits offered by this job

HIP PPO health plan

Retirement plan

Tuition reimbursement

FreeU education benefit

Career development

Job summary

Abbott in Illinois is seeking a senior IT Quality and Regulatory Assurance leader to govern the Software Life Cycle, CAPA, and audit readiness within global IT. This onsite role partners with Quality, Regulatory, IT, and business teams to ensure compliant delivery of life‑saving technologies.

You will drive risk‑based decisions, mentor project teams, and coordinate system validation and quality oversight across planning, development, validation, implementation, and maintenance, aligning with

Qualifications

• 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.

Responsibilities

• Lead, manage, plan, and coordinate operational and administrative activities within IT Quality and Regulatory Assurance area.
• 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.
• Provide independent quality oversight, direction, and consultation to project teams, system owners, and business stakeholders.
• Manage stakeholder relationships and escalation processes to achieve compliant outcomes.
• Escalate significant compliance risks and recommend appropriate mitigation strategies.

Skills

Quality assurance

Regulatory compliance

Software validation

Software development

Risk management

Education

Bachelor’s degree or equivalent experience

Tools

GxP

CAPA management

Quality Management System (QMS)

Audit readiness tools

Job description

Abbott in Illinois is seeking a senior IT Quality and Regulatory Assurance leader to govern the Software Life Cycle, CAPA, and audit readiness within global IT. This onsite role partners with Quality, Regulatory, IT, and business teams to ensure compliant delivery of life‑saving technologies.

You will drive risk‑based decisions, mentor project teams, and coordinate system validation and quality oversight across planning, development, validation, implementation, and maintenance, aligning with