Senior Manager, Qualified Person

Company Description

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.

Job Description

We are currently hiring a Qualified Person (QP) to join our team in Westport. As a QP, you will have QA oversight of all activities in the business unit ensuring the necessary GMP requirements are upheld. The QP will hold responsibility for certifying all batches manufactured in the business unit against the requirements of   marketing authorization and the principles of GMP. The QP is legally responsible for batch disposition and must be listed on AbbVie’s manufacturing authorizations. The role will provide support to the Director of QA in addition to the Business Unit Leader in achieving the required goals and objectives; meeting customer requirements and the necessary regulatory requirements as laid down by the FDA, EU and regional Ministries of Health as relevant. 

• The QP will approve all records generated by the business unit, including but not limited to batch records,  exception reports, validation documents and product quality review reports.  
• Provide quality input for all activities undertaken within the business unit. 
• Represent the company in all business unit for Agency inspections, ensuring the unit is inspection ready. Ensure any non-conformances and open commitments related to the business unit are addressed. 
• Evaluate and disposition all batches manufactured in the unit. 
• Provide guidance on all non-conforming material/  batches. Direct the investigation and determine the release disposition of such material/product. 
• Participate in the business unit OPEX activities providing quality input 
• Direct the activities of the QA and Product release personnel within the business unit to ensure product is released and activities are undertaken in a compliant manner. 
• Motivate   employees to ensure all activities are performed in a GMP compliant manner through effective communication.  
• Provide direction to all quality personnel based in the Business Unit, including QC, Product Release, Compliance and Bioassay 
• Provide guidance to all business unit functions to ensure activities are completed in a GMP compliant manner. 
• To agree with the Director of QA and Business Unit Leader the delivery of the company quality plan and global regulatory requirements providing appropriate, timely information as required. 
• Anticipate, understand and address the changing regulatory environment of the Pharma/Medical Device industry. Assess quality implications of new regulatory guidance and imp