Senior Specialist, Global Change Management & Risk Control

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.

Responsibilities

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.

Significant Work Activities:

Frequent to continuous computer usage (greater or equal to 50% of the workday) is required

Bachelor’s degree preferably in Engineering or Science

Six (6) years of experience within the Biologic manufacturing process, addressing change management topics.

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

Experience in Change Management Quality Systems such as One Track, Trackwise, or others.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this roleat the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

This job is eligible to participate in our short-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount isearned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that areallocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolutediscretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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