Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
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.
Bachelor's degree or equivalent experience
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
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.