We are now hiring a Qualified Person to join our growing site in Ballytivanan. The Qualified Person (QP) at Abb Vie 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 Eudra Lex 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

• 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)

Abb Vie 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

Abb Vie'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 Abb Vie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.