About this role
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 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) 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.
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