Sr. IT Compliance Analyst - CAPA

Abbott • Waukegan, IL

1d • $78,000 - $156,000 • Onsite

About The Position

This role is for a Sr. IT Compliance Analyst - CAPA at Abbott's Lake County, IL location. The position involves establishing and maintaining relationships with IT organizations and business functions, acting as an IT Compliance expert for investigations and corrective actions, and serving as a source of information on IT Compliance needs and the regulatory environment. The role requires leading IT Compliance activities for CAPA event evaluations, investigations, and resolution planning, assembling cross-functional teams, and driving CAPA events to completion using project management skills. The analyst will ensure investigations and remediations are completed on schedule, apply IT project delivery and compliance knowledge, monitor implementation plans, and escalate issues as needed. The role also involves preparing and approving documentation, capturing and reporting CAPA metric data, and applying AI technologies to improve quality processes and compliance activities.

Requirements

• Bachelor’s Degree or equivalent certification or experience.
• Overall 5+ years of experience in IT project delivery, IT application support, SLC methodologies with about 2-4 years in CAPA and regulated quality systems environment.
• The individual should either be a CAPA Certified Event Owner or be willing to obtain certification.
• Strong analytical thinking, sound judgment, consultative skills, and the ability to effectively partner with both IT management and technical teams.
• Proven ability to build strong stakeholder relationships, drive results, and communicate effectively through both verbal and written channels.

Nice To Haves

• Familiarity with AI technologies and agent-based solutions to improve quality processes.
• AQR certifications.
• Life sciences industry background

Responsibilities

• Leads the IT Compliance activities for specific CAPA (Corrective and Preventive Action) event evaluations, investigations, and resolution planning.
• Assembles CAPA CFT (cross-functional team) team with all needed parties/expertise to effectively and efficiently address assigned CAPA events.
• Provides understanding and leadership of CAPA processes, SLC, validation and compliance processes/procedures to CAPA CFT (and other stakeholders as needed).
• Exercises Project management skills to drive for completion of CAPA events (assignment of action ownership, details, milestone dates).
• Ensures CAPA events are investigated and remediated according to schedule.
• Applies IT project delivery, application support and compliance knowledge and experience to investigations.
• Monitors implementation plan and effectiveness check due dates and work with BTS IT owners to ensure implementations are completed on time.
• Escalates status, implementation, and effectiveness issues to CAPA management as needed.
• Prepares and approves documentation per policy and procedure to support CAPA activities.
• Accountable for capturing, reporting, and evolving the CAPA metric data for BTS. Prepares management review metrics for upper management communications and provides input as needed for GMR metrics.
• Apply AI technologies and agent-based solutions to improve quality processes, support investigations and compliance activities, and expand AI expertise through ongoing learning and best practice adoption.
• Develops the CAPA strategy and approach for CAPA events.
• Assembles and leads CFT (virtual or onsite) to develop, review and approve CAPA documentation (evaluation, investigation, containment, resolution, implementation, and effectiveness checks) in support of IT quality activities.
• Applies critical thinking and reasoning skills to incorporate CFT input into a well-organized and complete CAPA event record.
• Implements technical writing and clear and concise conclusions in the documentation of CAPA events.
• Performs work using BTS Quality System methodologies, processes, and tools to ensure IT Compliance.
• Resolve issues that may delay the CAPAs or otherwise subject the company to financial or regulatory risk.
• Support the development and oversight of AI agents and AI-enabled processes, ensuring responsible AI usage, compliance with company policies, and continuous advancement of AI knowledge and capabilities across the organization.
• Works with minimal management direction. Drives completion of CAPAs by organizing and monitoring the efforts of CAPA SME teams.
• Independently conceives and develops approaches to the solution of CAPA events which require application of IT compliance principles.

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.
• Health and wellness benefits

What This Job Offers

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