Job Description We 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 Review Supplier Approval Program CAPA Change Control and Documentation Training Inspection Readiness & Management Internal Audit Quality & Technical Agreements Continuous Improvement and Simplification Initiatives Developing 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 policies 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 Quality Director as required. Qualifications Third 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 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.
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