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Senior Manager, Non-Product Software

Company: Abbott
Location: Lake Forest
Posted on: November 14, 2019

Job Description:

Senior Manager, Non-Product Software REQ******** NA-USA-Illinois-Lake Forest Position Title: Senior Manager, Non-Product Software Location: Lake Forest, IL DO WORK THAT MATTERS At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals. We have an exciting opportunity for a Senior Manager, Non-Product Software Job Description within our Abbott Rapid Diagnostics business located at Lake Forest, IL. In this role, you will be responsible for managing the Non-Product Software group supporting validated systems used in the manufacture and development of rapid diagnostic products such as instruments, software, and lateral flow devices at the global ARDx sites. Abbott Rapid Diagnostics (formerly Alere) is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.RESPONSIBILITIES Provide Non-Product Software oversight, guidance, and subject matter expertise for the global network, with direct reports working in regions, supporting the local business needs Implement software quality assurance and validation strategies for the division to facilitate consistent practices and ensure compliance with applicable corporate and divisional policies and procedures Work closely with the global ARDx sites to establish and drive remediation and improvement plans associated with Non-Product Software validation Support audits in related areas and any associated resolution of observations Initiate process improvements to reduce computerized systems development and validation cycle time and expense Administer Division Software Quality Assessment program Provide guidance and influence on policies, processes, and procedures used for regulated aspects of computerized systems development Establish and maintain IT application and infrastructure quality assurance governance models Provide expert consulting service in quality assurance activities that support computerized systems Ensure that computer software or automated data processing systems used in production or quality systems is validated for intended use per established protocols Oversee and provide guidance on software validation such as; software used in manufacturing; process validation; spreadsheets; electronic batch records; electronic signature systems Strategic, multi-disciplined thinker who develops proposals to address issues and resolve risks Serve as the division liaison for corporate initiatives linked to Non-Product Software Understand global, regional and country specific quality requirements to support international compliance Ensure ARDx employees fully understand the compliance expectations of their position as they relate to software validation requirements, corrective/preventive action and associated investigations, good documentation practices, quality system changes and the subsequent implications and impact of their decisions Manage budget, staffing, and resources as required BASIC QUALIFICATIONS Bachelor's Degree in an Engineering, Quality, or Life Science discipline, or significant experience (minimum of 10 years) in a software development or quality support function Quality/ Compliance management system experience in a regulated healthcare environment (e.g., 21 CFR part 820, ISO 13485) Overall management experience Software development and validation in a regulated industry Work collaboratively and communicate effectively with awareness of global cultural differences About Abbott 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. Connect with us at ************** , on LinkedIn at ********************************** on Facebook at *********************** and on Twitter @AbbottNews and @AbbottGlobal. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please send an email to *********************. Technology General & Administrative Full-time

Keywords: Abbott, Glenview , Senior Manager, Non-Product Software, IT / Software / Systems , Lake Forest, Illinois

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