Our location in Lake County, IL currently has an opportunity for an IT QUALITY & REGULATORY ASSURANCE MANAGER.

WHAT YOU’LL DO

Lead, manage, and coordinate IT Quality and Regulatory Assurance activities to achieve compliance with regulations and industry standards, while minimizing impact on Global IT Organizations.

CORE JOB RESPONSIBILITIES

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Provides leadership to maintain a compliance and consistency. 
• Area of responsibility may include Quality Systems, SLC, document center, regulatory activities.  Ensure compliance through Corporate level policies, supporting tools and training. 
• Manage associated budget responsibilities for single departments.
• Organizational responsibilities or expertise in the following areas:

• Abbott software life cycle process and internal audit knowledge.
• Quality event occurrence, investigation and documentation for any suspected policy, process, or procedure non-conformity or production related system or event (IT CAPA).
• Structure, conformance and adherence of policy, process and procedure documentation in accordance with Abbott\'s quality system. 
• Controlled physical library repository for the storage of controlled records (including policy, process and procedure) in accordance with the Abbott retention schedule AQ0501.A Record Retention Process
• Regulatory support and SOX Reporting oversight providing the SOX PMO with completed Tier-1, Tier-2, and Tier-3 SOX templates.
• Coordination and oversight of external and internal audit activities, including audit process expertise, information repository sources, and inspection readiness including the audit lifecycle process

POSITION ACCOUNTABILITY & SCOPE

Accountable for global compliance to IT policy and procedures that have specific responsibility in quality, documentation and adherence to global regulations.

MINIMUM EDUCATION:

Bachelor’s degree or equivalent experience

EXPERIENCE REQUIRED:

• Knowledge of regulations and standards that affect the health care industry.
• 8+ years combined experience in software development, validation, and/or quality systems.
• 1-3 years’ experience in a regulated software development / validation environment.
• 1-3 years’ experience in leading software validation efforts, providing software quality assurance support, providing quality system support to IT systems.
• 1-3 years’ experience in GxP quality systems for IT, Pharma, or Device.

SUPERVISORY / MANAGEMENT RESPONSIBILITIES

Up to 5 direct/indirect reports

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives, and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities