Quality Systems Manager

Job Description We are now hiring a Quality Systems Manager for our Ballytivnan site in Sligo . This role will be responsible for a team and to coordinate 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. The Quality Systems Manager is responsible for developing and managing a Quality System, ensuring compliance by all departments and personnel with all applicable Regulatory Authorities and AbbVie requirements. Key responsibilities include: The Quality Systems Manager is responsible for developing and managing a Quality System, ensuring compliance by all departments and personnel with all applicable Regulatory Authorities and AbbVie requirements Is a site SME on Quality Systems issues and provides guidance on same. Contributes to the successful delivery of site CJR’s and Goals. Leads the delivery of new Quality Systems initiatives. Provide technical leadership to functional areas and collaborates with key stakeholders. Promotes department goals by selecting, motivating, and training capable staff. Contributes to Talent Management of teams within the organisation and to the development of the team to meet evolving business needs Preparation 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 Biologics Quality Director as required. Qualifications Third Level Qualification in Science, Quality or Engineering to Degree Level (Masters Preferable) Minimum of 8 Year’s Experience in the healthcare/pharmaceutical/biopharmaceutical industry Minimum of 3 Years Supervisory/People Management experience Demonstrated audit/inspection management experience Deep knowledge of GMP Requirements and Regulations. Ability to make Quality decisions and to run the business while keeping patient focus and safeguarding the company’s reputation. Additional Information AbbVie 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