Analyst II, Total Quality Management
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.
AbbVie Data Science is the best-in-class team within its cross-industry peer group. We are responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is a key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences.
- Accountable for the utilization of the eight essential TQM principles in support of the established management system.
- Utilizes the seven basic tools of total quality management, as well as lean principles to support process improvement.
- Utilizes established change management framework to successfully drive process, technology and organizational change.
- Accountable for the successful execution of assigned process improvement projects within the data and statistical organizations and across clinical development.
- Utilizes data-driven approaches (e.g., KPIs, resource planning, balanced scorecards) to communicate the quality, speed, agility and culture of the clinical development organization. Utilizes analytical tools to support analysis that reflect contributors to key metrics, root cause analyses, and process waste.
- Provides training to the data and statistical organizations on best practice methodology for continuous improvement, change management, and quality by design.
- If assigned, supports organizational interests at governance meetings, quality meetings and regulatory agency inspections. May include direct or indirect supervision of staff. Mentors junior team members and Data Science Associates.
- Maintains a business process framework that ties Data Science processes to those across clinical development. Builds strong relationships with all stakeholders. May include direct and/or indirect supervision of staff.
- Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development.
- Supports major strategic operational engagements with both internal and external stakeholders.
- Bachelor's degree in engineering, business, management Information Systems, computer science, life sciences or equivalent. Master’s preferred.
- 6+ years’ work experience in pharmaceutical, research, data management, health care or similar, with a focus in quality, operations and project leadership. TQM certification and/or Lean Six Sigma Black Belt is preferred. PMP certification is preferred.
- Demonstrated understanding of the clinical development process.
- Demonstrated effective communication skills.
- Demonstrated problem-solving and analytical skills.
- Demonstrated leadership traits and ability to influence without authority.
- Demonstrated ability to lead successful initiatives at the organizational level.
Key Stakeholders: Clinical Program Development, Site Management and Monitoring, IT, Drug Supply, Data
and Statistical Sciences, QA, Finance
Significant Work Activities
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.