AbbVie's 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 people's 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 www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Purpose:

Describe the primary goals, objectives or functions or outputs of this position.
Support manufacturing operations in the resolution of events and documentation discrepancies. Provide guidance for product/process impact analysis, investigations and risk based evaluations in support to plant events.
Responsible for implementing and maintaining the effectiveness of the Quality System.

Responsibilities:

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Support routine operations to ensure that all quality goals are met, and all practices and procedures comply with AbbVie policies and applicable regulations for the Quality areas under his /her responsibility.
• Ensures investigations of plant events are evaluated in a timely manner; completed thoroughly and documented accurately in the plant CAPA system.
• Performs product impact analyses for plant events and places product on QA hold where appropriate.
• Participates on the Validation Review Board as the Manufacturing Quality Assurance function.
• Approves standard operating procedures; change management and risk management documents. Ensures all documents are in compliance with Abbvie global procedures and regulatory requirements.
• Approves calibration requests, calibration out of tolerance and preventive maintenance records. Ensures that these documents have appropriate justifications according to product /process limits established.
• Demonstrates accountability and responsibility of EHS performance and compliance.
• Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
• Oversees manufacturing operations to ensure practices are in alignment with approved procedures.
• Provide support to the Compliance team during internal and external audits as required.

Qualifications:

• Bachelor's degree in Biotechnology, Biology, Chemistry or Engineering. Master's degree: not required but desired.
• Quality/compliance management skills. This position requires knowledge of quality / compliance /Risk management as well as regulations and standards affecting biological products.
• Experience in Health care industry – 2 years. Experience in Pharmaceutical industry - 2 years. Total combined minimum years of experience required – 2 years. (Not necessarily the sum of the above)
• Fast paced and continuously changing environment. Subject to work with multiple interruptions and under reasonable pressure due to the nature and function of the area.
• Conform to EH&S management system requirements, promote continuous improvement, and consider EH&S aspects during the design and change process.

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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html