Senior Specialist IT Quality

Abbott • Waukegan, IL

12d • Onsite

About The Position

The Senior Specialist - IT Quality provides quality oversight and compliance leadership for regulated data center facilities, utilities, and equipment supporting healthcare and GxP - relevant IT operations. This role ensures that data center physical infrastructure and supporting systems are operated, maintained, and controlled in compliance with applicable regulatory requirements, internal quality standards, and industry best practices. The position partners closely with Facilities Engineering, Data Center Operations, IT Infrastructure, Quality, and Safety teams to ensure inspection readiness, lifecycle control, and sustained reliability of critical data center environments.

Requirements

• 3+ years of experience in a regulated quality systems environment, preferably within: Healthcare, pharmaceutical, biotechnology, or medical device industries
• Data center operations, facilities engineering, or critical infrastructure support
• Demonstrated experience in facilities, utilities, or equipment qualification and compliance.
• Strong analytical, judgment, and consultative skills with the ability to work across Facilities, IT, and Quality organizations.
• Knowledge of regulations and standards that affect the health care industry.
• Bachelor's degree or equivalent experience

Responsibilities

• Ensure that data center facilities, utilities, and equipment comply with applicable regulatory, corporate, and quality requirements.
• Ensure appropriate qualifications, documentation, and change control for regulated facilities and infrastructure.
• Oversee commissioning, qualification, and requalification activities for data center infrastructure and equipment.
• Review and approve lifecycle documentation, including: Installation, operational, and performance qualification protocols, Maintenance and calibration records.
• Ensure infrastructure remains in a validated and compliant state throughout its operational lifecycle.
• Ensure production and process controls are established, implemented, and maintained for data center facilities, utilities, and equipment supporting regulated IT operations.
• Provide quality oversight and approval for changes impacting regulated data center facilities, utilities, or equipment.
• Ensure facilities- and equipment-related documentation is complete, accurate, and inspection-ready.
• Review nonconformances, CAPA, deviations, incidents, excursions, and infrastructure-related events impacting environmental or system integrity.
• Ensure timely investigations, root cause analyses, CAPA development, and effectiveness checks.
• Support and participate in internal audits, supplier audits, and regulatory inspections involving data center infrastructure.
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Perform work using standard methodologies, processes and tools to ensure IT Compliance.
• Responsible for implementing and maintaining the effectiveness of the quality system.
• Responsible for assessing risk and applying risk-based approach strategies without compromising compliance.
• Perform Quality function related to process improvements, metrics collection and analysis, and adherence to defined Abbott practices.
• Create, review and approve quality documentation in support of quality activities.
• Establish project tasks and timelines and is held accountable to them.
• Identify potential process improvements.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior