Company DescriptionAbbVie'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 DescriptionWe are now hiring a Compliance Manager to join our team on our site in Manorhamilton Road, Sligo. This person will lead compliance for the site, including various quality compliance areas including inspection readiness, supplier management, training, and documentation. This is an opportunity for someone to take on a key role on our NPI and early-stage commercial site of choice within our network and manage a team of quality experts who ensure our success.
The main responsibilities include:
To co-ordinate the development and maintenance of the company's quality system in compliance with all applicable regulatory requirements and to ensure that products manufactured at AbbVie meet requirements of GMP, end users, Regulatory Authorities, and the company.Responsibility for Compliance with Quality System including, inter alia:Management ReviewSupplier Approval ProgramCAPAChange Control and DocumentationTrainingInspection Readiness & ManagementInternal AuditQuality & Technical AgreementsContinuous Improvement and Simplification InitiativesDeveloping and managing a Quality System, ensuring compliance by all departments and personnel, with the requirements of the regulatory agencies as well as Abbvie Quality Assurance policiesPreparation and maintenance of Site Master File, Quality Manual, and Quality Plans.Ensuring that products manufactured at Abbvie meet requirements of end users, Regulatory Authorities, and of the company.Developing and maintaining performance measurements of the quality system and reporting on this at the management review meeting and during quality performance meetings.Liaising with Abbvie Quality and Compliance Group, FDA, HPRA, and other Regulatory bodies.Act as Designee for Quality Director as required. QualificationsThird level qualification in a science discipline with 8 years' experience in the pharmaceutical industry.8 years industrial experience gained in an FDA and EMA approved pharmaceutical or device environment.Minimum 5 years supervisory experience.Demonstrated Audit/Inspection Management experience. Additional InformationAbbVie is an equal opportunity employer and 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.
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
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