Software Quality Assurance ensures computer system software meets requirements and is validated throughout the system's and the drug development's life cycles. The functional group will ensure high quality products and data compliant with GxP regulations, internal policy/procedures as well as FDA (GCP/GLP/GMP/21CFR Part 11), SOX, HIPPA, and International (ICH, Annex 11). We have a challenging opportunity for a IT Quality Consultant based in North Chicago, IL., reporting to the Senior Software Quality Assurance Manager.
Key responsibilities include:
•Author, review/audit, and approve project documentation associated with the SLC to support applicable federal and regulatory requirements
•Review/approve various qualification/validation plan documents, test strategies, test documents, summaries, and certification packages and associated deliverables as appropriate
•Ensure recommended changes/improvements to support the US Commercial Systems are compliant to the internal and external policies, processes and procedures
•Establish quality system requirements for the US Commercial Systems
•Provides project quality leadership for validation or SLC activities
•Create and apply risk-based approach strategies effectively and efficiently without compromising compliance
•Approve key project deliverables
•Serves as expert resource with regards to the US Commercial Systems and compliance issues
•Generate or review and provide feedback on various documents related to qualification/validation eg calibration, SOPs, VMPs etc
•Lead process improvement projects
•Bachelors Degree or equivalent experience and minimum of 4 years of experience in Quality Assurance or related field such as regulated GxP environment in qualification/validation, documentation or compliance.
Key AbbVie Competencies:
•Builds strong relationships with peers and cross functionally and with partners outside of the team.
•Learns fast, grasps the “essence” and can change course quickly where indicated. Raises the bar and is never satisfied with the status quo.
•Creates a learning environment, open to suggestions and experimentation for improvement.
•Embraces the ideas of others, nurtures innovation and manages innovation to reality
This position is part of AbbVie’s Information Security & Risk Management (ISRM) team. We are here to put our partners in a position to succeed. We do it by providing the knowledge, tools, and support they need to effectively use data and technology while also effectively managing risk.
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.