Program Manager, QA

Job Description We are hiring a Quality Program Manager for our Manorhamilton Road site in Sligo for a 12-month Fixed Term Contract. The Quality Program Manager is responsible for developing and managing the Quality Programs team with responsibility for ensuring successful transfer of new products to AbbVie Sligo in accordance with applicable regulatory requirements and AbbVie procedures and policies, from product development right through to commercialization. Additional product transfers that the Quality Program Manager is responsible for supporting include commercial product transfers (assurance of supply initiatives) and transfers of products not owned by AbbVie. Furthermore, the Quality Program Manager is responsible for quality governance over key site strategy projects, as defined through the Project Management forum. Responsibilities: New Product Introduction Responsible for implementing and maintaining the effectiveness of the integration of new products into the AbbVie quality system. Ensuring the new products manufactured at AbbVie Ireland NLB.V. meet requirements of applicable regulatory requirements and AbbVie procedures and policies. Site Quality Lead responsible for all new product transfers to the site from development through to commercialization, liaising closely with local and external cross functional teams to provide direction on quality concerns and ensure appropriate mitigation to address potential risk. Managers Quality technology transfers and set up/revises internal processes and procedures. Collaborate with CMC QA, R&D, S&T, and other functional groups to maintain roles and responsibilities, identify potential quality issues, obtain an understating of the quality compliance, and resource needs of the site and provide input on quality concerns. Coordination of site review of new product related material specification documents including but not limited to, intermediate specifications, API specifications, Drug Product specifications, raw material specifications, and excipient specifications. Support review and approval of new product related analytical Test Method Transfers and/or validation. Support the management of new product related exception documentation including the generation of corrective and preventative action to prevent reoccurrence. Monitor the outstanding CAPA’s from identified risks to ensure 100% adherence of all site commitments for EHS and Quality. Develop and deploy robust processes and procedures for effective assessment and evaluation, of design, system, and business risk. Generation of product transfer documentation to attest the completion of product transfer deliverables, in advance of the applicable product transfer stage gate review. Interfaces with internal auditors and outside regulatory agencies/auditors as the subject matter expert for new products and technology transfers. Escalate issues appropriately. Act as Designee for Quality Director as required. Adheres to and supports all EHS & E Standards, procedures and polices Project Management Responsible for quality governance over key site strategy projects, as defined through the Project Management forum. Qualifications A Bachelors Degree in a relevant discipline. A minimum of 3 years experience in a Quality role within a GMP environment. Excellent knowledge of regulatory requirements is essential. Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures. Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis 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