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 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 projectsCollaborate with suppliers and internal/external stakeholders to maintain compliant, efficient relationships and optimized processesEnsure compliance with EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice, Annex 16, marketing authorisations, and all regulatory obligationsCertify that batches are manufactured and checked per legal, GMP, specification, and authorisation requirementsOversee batch disposition (release or reject) based on comprehensive manufacturing and testing dataMaintain review and completion of all necessary production and quality documentation, ensuring records are accurate and endorsedAssess and resolve daily quality issues and deviations, maintaining high standards of expertise and attention to detailAuthorize and evaluate deviations or planned changes, participate in notification processes with regulatory authoritiesEnsure principal manufacturing and testing processes are validated, audit readiness maintained, and improvements drivenInitiate and oversee additional sampling, inspection, tests, or checks as needed due to deviations or changesContinuously develop technical/scientific knowledge and expertise for existing and new product typesFoster a culture of safety, EHS excellence, integrity, and continuous improvement within the organizationPerform other duties as assigned
Qualifications
Bachelor’s degree in a science discipline and 5+ years’ experience in an FDA/EMEA pharmaceutical environmentMSc (or equivalent) meeting QP qualification per Directive 2001/83/EC, Article 492+ years’ aseptic processing experience, preferably in a quality functionDemonstrated decision-making, problem-solving, and communication skillsExperience in leading teams and supporting cross-functional groupsExperience 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