AbbVie helps people around the world live better days and better lives each year. And that takes all of us.

　　Welcome to AbbVie!

　　AbbVie employees work every single day to discover and address many of the world's most pressing health challenges. Our work helps people live better lives. When you have patients depending on your solutions, you look for the best people and, when we find them, we make it our business to treat them well.

　　We are currently sourcing a Senior Quality Compliance Analyst to join our high performing Quality team in Westport. In this role, you will be responsible for QA activities in support of all aspects of commercial activities at the site, ensuring that the Biologics facilities meet the required GMP standard for commercial manufacture.

　　Interested? then read on....

　　In this role, you will:

　　• Assist the Associate Director, Quality Biologics in the management of key quality system elements including:

　　o Deviation management

　　o Change controls

　　o Supporting the Self-inspection programme

　　o Inspection Management: Coordinate site GMP inspections; Internal site preparation; pre-audit MOH requests; Response/ report compilation & issuance; Post audit commitment management

　　o Quality metrics

　　o Manage regulatory standard and guidance revision assessments

　　o Manage compliance initiatives program

　　o Provide input and lead were applicable site quality risk management initiatives

　　• Drive forward the quality processes at the site and the skills to ensure that compliance adds to the greater benefit of the facility

　　• Co-ordinate QMS management for area of responsibility and site overview

　　• Represent the quality function at the site ensuring quality compliance is upheld across the business unit and supporting functions as deemed necessary

　　• Provide the necessary guidance relating to quality activities

　　• Work to meet company goals and objectives, customer requirements and the appropriate regulatory obligations as laid down by the FDA, EU and regional Ministries of Health

　　• Provide quality input as required, providing direction on day-to-day activities as a member of the Biologics Quality Team

　　Still interested? for this role, you will have the following;

　　Education & Experience

　　• A relevant 3rd level science qualification with a proven track record in a quality discipline

　　• Clear understanding of working within a regulated environment

　　• Excellent communication skills

　　• Ability to use sound judgment to make effective decisions within appropriate timeframes

　　• Proven to be self-directed, self-motivated and ability to prioritise competing priorities

　　Does this sound like the right next career move for you? then apply today!

　　It’s important to remember, AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.

　　AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.