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 a Sr. Software Validation Specialist.

Leads and directs software verification & validation activities including reviewing user/software requirements documents, writing and reviewing testing documents (test plans/strategy and detailed test cases/instructions); executing and reviewing validation test cases based on project priorities. Oversee and coordinate day to day activities for validation teams including providing expertise in preparation/executing/compilation of validation packages as well as managing workloads.

WHAT YOU’LL DO

• Manage remediation projects/milestones for 2021

  • Provide verification/validation activities project estimates, assist with the validation impact analysis of new development & existing application portfolio, Lead/participate in software verification/validation test activities, Review/draft operating procedures.

• Ensures compliance to ISO 13485, 21CFR 820 Quality System Regulations, and other applicable regulations and standards by providing support for interpretation of regulations, performing gap analysis, and leading activities to implement improvements

• Ensure teams have well defined timeline and project plan

• Manage compliance, deliverables/templates and ensuring timely completion

  • Responsible for the application of QA/Compliance policies & procedures across sites

  • Provides leadership to maintain a compliance and consistency across teams and projects across sites

  • Area of responsibility may include Quality Systems, SLC, document center, regulatory activities

  • Ensure compliance through Corporate level policies, supporting tools and training

• Create, develop, and report metrics on the ongoing and pipeline projects

• Work with sites on cost, resource, and pipeline estimates

• Plan and implement power BI for sites to capture KPIs and metrics

• Coordination and oversight of external and internal audit activities, including audit process expertise, information repository sources, and inspection readiness including the audit lifecycle process

• Provide validation coaching to system owners on remediation projects for 2021

• Deliverable review to ensure thoroughness of:

  • Risk assessment

  • Protocols/test strategy

  • Architecture/Design

  • Timely completion

• Review procedures between ARDx, Sites and Other Divisions to identify gaps, overlap, and develop proposal for BU level standardized process/templates

• Coordinate Cybersecurity and Data Integrity actions for sites

  • Identify gaps and actions in 2021

  • Execute milestones for sites in 2022

• Identify KPIs and Metrics for BU and by sites to create an overall NPSW scorecard

• Help plan and execute Lean Process Project across multiple sites

EDUCATION AND EXPERIENCE YOU’LL BRING

• Bachelor’s degree in Business, Computer Science, Life Sciences, or related discipline. 

• Knowledge of regulations and standards that affect the health care industry.

• Overall 7-10 years of experience in software validation, software quality assurance, and/or quality systems in regulated GxP environment for IT, Pharma or Device.

• Experience with writing & executing software testing deliverables

• Ability to work on multiple projects and timelines concurrently

• Excellent coaching and guiding skills

• Proven expertise in problem solving and identifying solutions in regulated environment

• Ability to work in matrixed environment

• Strong organizational and follow-up skills, as well as attention to detail

• Experience working in a broader enterprise/cross-division business unit model preferred

• Ability to work in a highly matrixed and geographically diverse business environment

• Ability to work within a team and as an individual contributor in a fast-paced, changing environment

• Ability to leverage and/or engage others to accomplish projects

• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

• Multitasks, prioritizes and meets deadlines in timely manner