Specialist, QA Change Management

AbbVies mission is to discover and deliver innovative medicines and solutions 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 and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie please visit us at . Follow @abbvie on X Facebook Instagram YouTube LinkedIn and Tik Tok.

Job Description

AbbVies Quality Change Management function supports global and local internal manufacturing sites suppliers and Third-Party Manufacturers for Drugs Biologics Medical Devices and Combination products by ensuring completeness and compliance to procedure and regulatory requirements. Analyzes and collects data for changes to product or quality system intended to support continuous improvement. Uses expertise within a specific scientific area to ensure Change Management compliance through ongoing preparation and monitoring of conformance to established Change Management procedures and processes.

• Evaluates Change Records to ensure change request is complete and compliant with AbbVies global and local procedures and regulations before processing in the quality management system tool
• Serves as Quality approver for lower risk or no product impact changes in the quality management system tool. May consult with Product Quality team to approve Change Management records
• Collaborates with more senior members of the team to review or create change plans
• Compiles quality data identifies data trends and follows up with Change Management Record creator accordingly to resolve discrepancies based on those trends
• May serve as the Change Management Training point of contact on cross-functional teams assigning relevant curriculum to users providing needed on the job training as necessary
• Serves as a back-up for creating communications for Discontinuations and Market Expansions
• Prepares reports queries dashboards and landscape reports from the quality management system tool in order to distill insights and recognize discrepancies in the change record data that require follow-up. Sets up databases as needed in the quality management system tool
• Supports cross-functional team discussions and Change Review Board meetings by preparing agendas and documenting meeting minutes.
• May manage and process Document Change Control packages within the relevant document control quality management system.
• Develops monitors and enforces site-wide Key Performance Indicators (KPIs) for change management by identifying relevant metrics maintaining their accuracy and ensuring consistent application throughout the organization.

Qualifications :

• Bachelors degree in a scientific discipline or 5 years of equivalent experience required
• 3 years of relevant experience in Manufacturing QA or R&D in pharmaceutical biologics device or chemical industry required
• Demonstrated knowledge of and experience with quality systems change management corrective action and preventive action system and other key tools for managing global quality performance in a regulated industry
• Ability to work in a global and highly matrixed environment
• Strong communication skills both oral and written
• Proficient in computer skills and hands on experience with database management spreadsheets project management presentations word processing flowcharting and/or any other similar type of software

Additional Information :

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 role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors 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 is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion 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. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time