Process and Performance Excellence Liaison
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.
Serves as a primary interface between the client and the Process and Performance Excellence function. Strategic partner with key stakeholders in their areas of focus throughout full lifecycle of strategic initiatives and delivery of solutions – from defining business needs, project planning, development, deployment, change management, and end user adoption – that supports operational excellence in clinical trial execution.
•Responsible for understanding AbbVie's Quality System and Regulations related to GXP activities and the BPO framework and is able to translate to stakeholders
•Thorough understanding of Clinical Trial Management Systems and other associated systems for areas of focus
•Able to assess and mitigate the impact of process changes related to continuous improvements, inspection findings, and changes in regulations.
•Develop the strategy for process change and identify and engage relevant stakeholders within and outside of Development
•Understand the remit of Centers of Excellence (Process and Performance Learning, Learning Management Systems and Metrics, Clinical Process Compliance, Process Excellence) in order to leverage their expertise in support of the business process framework, regulatory requirements and Development functional areas.
•Strategic assessment of metrics and measures for their areas of focus
•Focus on continual evaluation and management to ensure operational excellence in area of focus
•BS or BA required; advanced degree preferred
•8+ years of experience in pharmaceutical, healthcare or regulated industry preferred.
•Experience in a leadership role with strong management skills in a complex matrix environment, preferably in the healthcare industry.
•Demonstration of successful execution of compliance and training strategy in a fast-paced environment managing multiple priorities effectively using innovative and creative solutions.
•Competent in the application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance).
•Demonstration of successful coaching/ mentoring, people management and communication skills in a matrix environment.
•Effective leadership skills with a proven ability to foster global team productivity and cohesiveness.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 5 % 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.