Job Description

About AbbVie
AbbVies 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 peoples lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, womens 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.

Job Title: Manager, Quality Assurance

Purpose:

The Quality Supervisor tasked with Change Plan Management is responsible for supporting local and global biologics change plan documentation. This includes, but is not limited to, change management planning, communication strategy and execution, meeting coordination, and partnering with end users to drive understanding and compliance to the global operating model. Understands relationship of documentation and implementation of change including aspects of risk assessment, specifications and regulatory requirements. This position will also support departmental initiatives as determined by management. Position will supervise 1-2 personnel.

Responsibilities:

* Manages a team within the quality organization of up to 2 direct reports. Responsible for the effective organization, administration, training and supervision of their functional area.
* 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 Local/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 local/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 local/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 Local/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
Qualifications:

* Bachelors degree required: preferably in Physical or Life Sciences, Pharmacy or Engineering
* Eight (8) years of experience within the Pharmaceutical operations, preferably Biologic manufacturing process
* 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

Significant Work Activities
N/A
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
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.