Abbott Supplier Quality Assurance Lead in Waukegan, Illinois
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 103,000 colleagues serve people in more than 160 countries.
*The role requires strong IT General Controls Audit experience, with CISA and ISO13485 Auditor certifications preferred. Experience in Life-sciences Quality Management and Vendor Risk Management is also preferred. *
Primary Job Function:
The role is responsible for ensuring that all BTS IT Suppliers that provide software, hardware and/or services for BTS and Abbott, are assessed and qualified to Abbott requirements. The role ensures that suppliers identified as IT or having IT risk, are determined as relevant for assessment and qualification following the established BTS supplier management process. The role also works with other IT and business stakeholders to determine and rate risks of assessed suppliers, that may also include recommending courses of risk treatment and timing of resolution. The role works with divisional and corporate supplier quality functions to ensure continuous improvement in the management of supplier risks.
Core Job Responsibilities:
The role owns the BTS supplier management process and procedure documentation and ensures compliance to Abbott’s supplier policy. The role ensures that the Approved Supplier List is maintained and that Periodic Review requirements are fulfilled. As part of the execution of the supplier assessments, the role supports the process and collaborates with appropriate IT and business stakeholders to ensure assessments are completed timely and to requirements. From time-to-time, it may be necessary to attend an on-site audit to provide subject matter expertise, particularly in a for-cause-audit scenario. Upon identification of risks identified with a supplier, the role provides expertise to support mitigation and resolution solutions with Abbott and supplier representatives. During inspections, the role may be required to present evidence of the supplier management process to inspectors or ensure audit backroom staff have the necessary evidence and any other materials required for Abbott to respond effectively to requests. Continuous improvement is important to the health of Abbott’s Quality System, and as such this role participates in the Supplier Community of Practice and related forums, representing BTS, and ensures learning and improvements are included in the BTS supplier management program.
Strong analytical skills and the ability to organize work in a logical, thorough and succinct manner. Highly self-motivated, goal orientated, and self-directed Deep understanding of health and life science industry regulations, standards and guidance, and the implications for suppliers engaged in supporting Abbott’s business Deep understanding of IT controls management, application and infrastructure security controls, and lifescience-specific IT controls risks and how they apply to suppliers Familiarity with risk management principles, regulatory requirements and, industry best practices Demonstrated ability to operate and innovate in a small team with a fast‐paced environment, balancing both strategic and tactical needs Flexibility to adapt to changing assignments and ability to effectively prioritize Effective with written and verbal in English communications at all levels, providing input and regulatory guidance to project teams, management and business partners The role must maintain compliance expertise and be effective at applying requirements into the IT and business environment that supports business goals and maintaining a compliant state
The position works with senior BTS management and execution teams to ensure that the organization understands its responsibilities for supplier quality management and supports the program to ensure Periodic Reviews, Action Plans, Audit Plans, Audit execution and risk remediation activities are completed timely and to quality requirements. The position also works with divisional and corporate supplier quality functions to improve Abbott’s overall management of supplier risk. Lastly, the role works with Information Security and Risk Management to ensure Quality requirements are adequately represented in the overall Vendor Risk Management program.
Bachelors Degree in Science or equivalent or Information Technology or equivalent plus 6+ years of related work experience with IT general controls management and FDA regulated IT controls with respect to Data Integrity.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
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