This position does not require Travel. Change Management and risk control Specialist is responsible for support global biologics change plan documentation which include 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 with 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 assessment 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; monitor 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.
Qualifications:
- Bachelor’s degree preferably in Engineering or Science
- Six (6) years of experience within the Pharmaceutical operations, preferably Biologic manufacturing process with Technical writing expertise.
- 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 plan, 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 in English and Spanish.
Additional Information
- Significant Work Activities and Conditions: N/A
- Travel: No
- Job Type: Experienced
- Schedule: Full-time
