Job Information
Abbott IT Quality & Regulatory Assurance Manager in Maple Grove, Minnesota
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 114,000 colleagues serve people in more than 160 countries.
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
Career development with an international company where you can grow the career you dream of.
Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) education benefit - an affordable and convenient path to getting a bachelor’s degree.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
Provides senior-level consultation and direction to functional areas (including Software Quality and DevOps teams) on IT Quality policy, process, and procedures. Leads the IT Quality activities across multiple projects/client areas. Ensures that documentation complies with policy and procedure requirements in conjunction with internal and external business and technology partners. Leads in setting quality and compliance strategy and vision to meet business objectives.
Train and educate the appropriate business and IT communities on quality, compliance and standardize best practice systems as appropriate.
The role reports to the Senior Manager IT Quality and is within the IT Quality & Regulatory Assurance organization. The role works with the senior levels of the BTS IT organization as well as leaders across Abbott’s Quality Organization to drive improvements in BTS SQA Operations. The role works closely with peers and lower levels of BTS IT to sustain a quality mindset within the IT organization. Position is accountable for all phases of the SLC activities and works directly with BTS IT, Divisional Quality and relevant Process Owners. Provides quality guidance to less experienced staff. Acts as a mentor to lower-level individual contributors.
What You’ll Work On
Ensures IT validation packages comply with applicable Corporate and Divisional Policies and procedures.
Works autonomously with related IT contacts and the business process SMEs for this purpose.
Drives the GXP Inspection Support and defends the validation strategies to internal auditors, regulatory authorities, and other certified bodies.
Provides IT validation subject matter expertise.
Supports Software Development teams as SQA lead for the automated testing and implementation of regulated IT applications.
Ensures continuous improvement and gives input related to the validation strategy for IT changes.
Coordinates the introduction of new strategic methodologies; supports and approves the overall validation of global regulated applications.
Apply SQA Engineering principles throughout the Agile or Waterfall Software Life Cycle to identify defect and design flaws.
Collaborates with the development team to build compliance capabilities in order to assure the quality of the deliverables and ensures business needs are being met.
The role must be familiar with Quality Risk Management principles and practices and will guide teams and management with risk-based decision-making capabilities.
Applies Good Documentation Practices and assists as appropriate with required documentation for compliance purposes.
Required Qualifications & Education:
Bachelor’s degree in computer science, Information Technology or equivalent.
8+ years of experience with IT Quality in the life science industry, or an equivalent combination of education and work experience.
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.
Strong knowledge of GXP regulations and software validation principles.
Working knowledge of 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 efforts
Effective written and verbal communication (in English) to all levels of management.
Preferred Qualifications:
Knowledge with Agile, and/or Lean software development practices.
Strong analytical skills and the ability to organize work in a logical and succinct manner.
Highly self-motivated, goal orientated, and self-directed.
Familiarity with automated testing and implementation
Familiarity with GitHub, JIRA, Selenium, Bitbucket, HP ALM and/or other automation/continuous integration tools
ASQ Certified Software Quality Engineer qualification is preferred.
Supervisory Responsibility:
- Leads a small team.
Apply Now (https://www.jobs.abbott/us/en)
- Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $95,000.00 – $190,000.00. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
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