Manager, Quality Assurance Change Management

The purpose of the Quality Assurance Change Manager role at AbbVie is to ensure the highest level of quality and compliance in our manufacturing operations. As the Quality Assurance Change Manager, you will lead change management activities, oversee QA IT system support and validation management support. You will manage a small team of professionals and collaborate with stakeholders to optimize change management strategies. By leveraging your expertise, you will drive a culture of continuous improvement and compliance. Join our dynamic and innovative team to make a meaningful impact on patient lives and shape the future of healthcare. Apply now to be part of our team and contribute to our mission.

Responsibilities:

• Areas of responsibility include Change Management, QA IT system support, validation management, documentation center and training. This position will manage a group of quality system professionals within the Plant QA group.
• Responsible for managing the quality systems, processes and documentation in support of manufacturing operations at the plant. Responsible for ensuring the quality system systems ae ensuring compliance with regulatory and company requirements.
• Primary QA IT system support which includes assessing impact of change, leading teams, ensuring training, monitoring implementation, reviewing and approving documentation.
• Manages, facilitates and leads change management activities, including alignment, coordination, implementation, and communication for internal and external resources.
• Partners with Subject Matter Experts across the business to understand their change management needs and complete timely and effective change plans using best practices.
• Owns the site change management metrics; identifies measures that assess the effectiveness of change management. Proactively communicates these metrics.
• 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.
• 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.
• Builds and optimizes change management strategies ensuring alignment with AbbVie projects. Facilitate change review meetings to review and approve change plans.
• Accountable to for the compliance of the change plan documentation to the applicable processes and procedures.

• Required: 4 Year College Degree and at least 10 years of professional experience in the Pharmaceutical/Medical Device industry
• Required: Previous change management leadership experience
• Required: Knowledge of GMP regulations and standards affecting pharmaceutical products
• Required: Previous technical writing experience
• Preferred: 5+ years experience in a manufacturing/finishing environment
• Preferred: Previous project Management experience
• Required: Strong analytical skills and attention to detail
• Required: Strong interpersonal relations / communications skills. Ability to effectively communicate across all levels of the organization.
• Required: Demonstrated experience of delivering positive results when working collaboratively across sites/functions

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.