About AbbVie
AbbVies 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 peoples lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, womens 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.
Responsibilities:
* 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.
Qualifications
Qualifications:.
* Bachelors 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 AbbVies mission
Significant Work Activities
N/A
Travel
Yes, 20 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
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.
Chicago, IL
AbbVie Inc. discovers, develops, manufactures, and sells pharmaceutical products in the United States, Japan, Germany, Canada, Italy, Spain, the Netherlands, the United Kingdom, Brazil, and internationally. The company offers HUMIRA, a therapy administered as an injection for autoimmune and intestinal Behçet's diseases; IMBRUVICA to treat adult patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma, waldenström’s macroglobulinemia, marginal zone lymphoma, and chronic graft versus host disease; VENCLEXTA, a BCL-2 inhibitor used to treat adults with CLL or SLL; VIEKIRA PAK, an interferon-free therapy to treat adults with genotype 1 chronic hepatitis C virus (HCV); TECHNIVIE to treat adults with genotype 4 HCV infection; and MAVYRET to treat patients with chronic HCV genotype 1-6 infection.
It also provides KALETRA, an anti-human immunodeficiency virus (HIV)-1 medicine used with other anti-HIV-1 medications to maintain viral suppression in HIV-1 patients; NORVIR, a protease inhibitor indicated in combination with other antiretroviral agents to treat HIV-1; and SYNAGIS to prevent respiratory syncytial virus infection at-risk infants. In addition, the company offers AndroGel, a testosterone replacement therapy for males; CREON, a pancreatic enzyme therapy for exocrine pancreatic insufficiency; Synthroid to treat hypothyroidism; and Lupron to treat prostate cancer, endometriosis, and central precocious puberty, as well as anemia.
Further, it provides Duopa and Duodopa, a levodopa-carbidopa intestinal gel to treat Parkinson’s disease; Sevoflurane, an anesthesia product; and ORILISSA, a non-peptide small molecule gonadotropin-releasing hormone antagonist for women with moderate to severe endometriosis pain. It has collaborations with Alector, Inc.; Janssen Biotech, Inc.; Galapagos; Bristol-Myers Squibb Company; and Calico Life Sciences LLC. The company was incorporated in 2012 and is headquartered in North Chicago, Illinois.