IT Quality Consultant

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 an 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 Enterprise Systems are compliant to the internal and external policies, processes, and procedures
• Establish quality system requirements for the Information Enterprise 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 Enterprise 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

• Bachelor’s Degree with 6 years of experience in a related field such as regulated GxP environment in qualification/validation, documentation, or compliance or equivalent experience.

Key AbbVie Competencies:

• Experience with GxP regulations, internal policy/procedures as well as FDA (GCP/GLP/GMP/21CFR Part 11), SOX, HIPPA, and International (ICH, Annex 11)
• 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.

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.