Job Information
AbbVie Qualified Person in Sligo, Ireland
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 (https://www.tiktok.com/@abbvie) .
Job Description
We are now hiring a Qualified Person to join our growing site in Ballytivanan. The Qualified Person (QP) at AbbVie Biologics Ballytivnan Sligo ensures pharmaceutical product quality, safety, and regulatory compliance throughout the entire manufacturing lifecycle, from production through to release. This key role also provides technical leadership, guidance, and people management, including leading teams and supporting cross-functional project groups.
Responsibilities
Provide technical leadership and guidance to functional areas, lead teams of up to 6 people, and support cross-functional teams and projects
Collaborate with suppliers and internal/external stakeholders to maintain compliant, efficient relationships and optimized processes
Ensure compliance with EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice, Annex 16, marketing authorisations, and all regulatory obligations
Certify that batches are manufactured and checked per legal, GMP, specification, and authorisation requirements
Oversee batch disposition (release or reject) based on comprehensive manufacturing and testing data
Maintain review and completion of all necessary production and quality documentation, ensuring records are accurate and endorsed
Assess and resolve daily quality issues and deviations, maintaining high standards of expertise and attention to detail
Authorize and evaluate deviations or planned changes, participate in notification processes with regulatory authorities
Ensure principal manufacturing and testing processes are validated, audit readiness maintained, and improvements driven
Initiate and oversee additional sampling, inspection, tests, or checks as needed due to deviations or changes
Continuously develop technical/scientific knowledge and expertise for existing and new product types
Foster a culture of safety, EHS excellence, integrity, and continuous improvement within the organization
Perform other duties as assigned
Qualifications
Bachelor’s degree in a science discipline and 5+ years’ experience in an FDA/EMEA pharmaceutical environment
MSc (or equivalent) meeting QP qualification per Directive 2001/83/EC, Article 49
2+ years’ aseptic processing experience, preferably in a quality function
Demonstrated decision-making, problem-solving, and communication skills
Experience in leading teams and supporting cross-functional groups
Experience as a QP on a license (preferred); sterile fill-finish manufacturing experience (desirable)
Additional Information
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