Manager, QA IT Systems
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Primary responsibility is to act as business system owner and Global Process Lead for SAP and LotSmart and support day-to-day business functions within SAP Quality Module (QM). The Manager QA IT systems will closely work with the SAP Quality System Integration Lead to improve SAP and LotSmart business processes and to establish the SAP Center of Excellence. Work with cross functional team members through the development/design process for continuous improvements of SAP QM and LotSmart functions. Provide review/approval for regulatory restriction updates. Ensure smooth roll-out of enhancements with exposure to site Qualified Persons and QA resources.
- Effectively manage and execute strategic business opportunities to improve SAP and LotSmart business processes
- Closely work with manufacturing sites to ensure smooth product release at finishing sites
- Ensure successful master data set up for LotSmart functions to support New Product Introduction (NPI) readiness per product filings/launches targets for AbbVie products
- Analyze business processes and elicit, analyze, and document continuous improvement requirements (CIRs) to support SAP QM functions
- Act as liaison between SAP integration team and designated site(s) for deployment activities
- Contribute to shaping AbbVie standard operating model for QM functions
- Ensure compliance with corporate and regulatory bodies as well as the completion of quality documentation and requirements.
- Provide consultation and training on SAP Quality Module (QM) and LotSmart functions to internal, affiliate, and cross-functional groups.
- Bachelor’s degree in sciences, engineering or other technical/scientific area. Engineering degree preferred
- Minimum 8+ years of experience Quality Assurance site and corporate level, Software Development, SAP Quality Management and/or related field such as regulated GxP environment in qualification/validation, documentation and compliance. Prior IT Application System Owner experience preferred.
- Experience leading technical professionals and global cross-functional teams
- Strong oral and written communication skills needed
- Drive, energy, and passion to advance AbbVie’s mission
Significant Work Activities
Yes, 20 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity 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.