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Job Details


Abbott

Manager IT Quality (31020461)

Pharmaceuticals

All

Yearly

Full Time

No

Waukegan, Illinois, United States

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 113,000 colleagues serve people in more than 160 countries.

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 107,000 colleagues serve people in more than 160 countries.

WHAT YOU’LL DO

  • Responsible for management and oversight of the BTS IT Validation Quality Management System, processes and improvement. Specifically, responsible for BTS SQA Operations and GXP Inspection Readiness improvements.

  • In addition, the role is key to driving a sustained culture of quality and compliance across BTS IT, ensuring management visibility of all key process performance measures and action plan progress.

  • Provide consultation to Divisional and Corporate counterparts on leveraging and consolidating quality and compliance best practices solutions for competitive advantage.

  • Assess, then train and educate the appropriate business and IT communities on quality, compliance and standardize best practice systems when appropriate.

  • In conjunction with internal and external business and technology partners, lead in setting quality and compliance strategy and vision to meet business objectives.

  • The role manages the daily operations and performance of the following BTS IT Quality and Compliance

  • functions:

  • Management of SQA Operational staff ensuring appropriate capacity, work assignment and

  • performance monitoring of staff and service provider compliance roles in support of infrastructure projects and maintenance activities. Management Review and QS metrics management and reporting.

  • Management and performance reporting of Quality Agreements with Divisions and Service Providers.

EDUCATION AND EXPERIENCE YOU’LL BRING

Education:

  • Minimum 4 year degree and/or 8 years in a comparable role in IT or a quality function.

Experience/Training Required:

  • Must have had prior experience with CAPA management, Quality System management, strong root cause analysis capabilities, ability to identify improvement opportunities, build business cases and drive improvement projects to resolution as agreed.

  • Certifications from ASQ and experience with ISO9001 or ISO13485 preferred.

  • Familiarity with document management practices. Prior experience as a SQA or management of an operational team within an IT project environment.

  • Experience with Software Lifecycle management, IT Change Management and Controls practices, reporting and senior management-level engagement.

  • Understanding of infrastructure related frameworks, processes and practices (e.g. ITIL, GAMP).

  • Knowledge of traditional and cloud-based IT Infrastructure platforms / components like Infrastructure as code (IaC), IaaS, SaaS, PaaS, AWS, etc.

  • Candidates with additional Data Integrity and/or cloud-based platform specific SQA experience will have an advantage in the selection process.

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

Learn more about our benefits that add real value to your life to help you live fully: [Register to View] , on Facebook at [Register to View] target="_blank">[Register to View] and on Twitter @AbbottNews and @AbbottGlobal.