Sr Analyst Global Change Management and Risk Control
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 .
The Change Management and Risk Control Specialist is responsible for supporting Global Biologics change plan documentation which includes the change risk evaluation. This includes, but is not limited to, change management planning, change risk assessment, communication strategy and execution, meeting coordination, and partnering with end-users to drive understanding and compliance to the global operating model. Supports Quality Risk Management tools within the Commercial Biologics PQA Organization. This function supports globally AbbVie manufacturing sites and TPM's where Commercial Biologics Products are manufactured.
- Creates and executes a structured change management methodology to develop detailed change management plans and ensure intended results are achieved; including planning, risk analysis, and implementation.
- Document and coordinate Global biologic change plans assessment and strategies in support of the end-user and functional impacted areas.
- Builds and optimizes change management ensuring alignment with AbbVie projects.
- Facilitate change review meetings to review and approve change plans.
- Conducts initial assessments of the risk of the global biologic changes to the quality, efficacy, and safety product. Review applicable risk and/or product documentation. Elevates to the Global Change Review Board as needed.
- Defines, with the collaboration of the cross-functional team, risk control elements that must be implemented to mitigate the identified risk for the global biologic changes.
- Defines and measures success criteria and monitors change progress with Process Teams, Project Manager and Global change Control Manager and able to leverage available metrics and reports to identify Change Management opportunities to better support and drive model adoption and improve collaboration.
- Owns Global Biologic change management metrics; identifies measures that assess the effectiveness of change management; monitors open actions. Proactively communicates these metrics.
- Support training efforts to provide input, documentation requirements for the change management training programs, and measurement to ensure ongoing success and drive desired cultural attributes.
- Bachelor's degree required, preferably in Engineering or Science
- Must be proficient in Soltraqs and/or Trackwise
- Six years of experience within pharmaceutical operations required, preferably in Biologic Manufacturing Processes
- Knowledge of GMP regulations and standards affecting pharmaceutical products
- Comprehensive knowledge and application of business and quality concepts
- Strong analytical skills and attention to detail
- Change Plans, SAP and LRMS experience is highly preferred
- Proven ability to adapt communication style for a variety of modes as well as for multicultural audiences
- Strong interpersonal relations / communications skills.
- Ability to effectively communicate across all levels of the organization
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)
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.