QA Regulatory Compliance Team Lead

ÞI For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”! Job Purpose This position is responsible for the management of Quality Assurance Regulatory Compliance activities at Janssen Sciences Ireland (JSI). These activities include; support for worldwide submissions of new drug clinical and commercial applications and post approval changes, change control support, manufacturing support, manufacturing license maintenance, Japan site accreditation maintenance, Global GMP license maintenance (for initial registrations and renewal) and Notarisation/legalization requests. What you’re great at: Excellent interpersonal skills Attention to detail Good decision-making capability Collaboration and team work Problem solving skills Customer focused Clear communication skills Adaptable and flexible Results and performance driven As a Quality Assurance Regulatory Compliance Team lead, your typical day may include: Provides guidance and training to a team of Regulatory Specialists in the execution of their duties Co-ordinates Regulatory Specialists to ensure timely management of all internal and external regulatory requests for JSI Provide mentorship to team members to ensure professional and personal development Oversees and reviews all regulatory requests prior to completion/submission Establishes effective partnerships across all functions in order to progress activities Promotes improvement projects Ensures contracts are in place and renewed as appropriate to support the volume of work within the team Provides regulatory support for routine manufacturing/Quality operations in conjunction with JSI CMCRA management Assist and support onsite Health Authority inspections In conjunction with JSI CMC Regulatory Affairs and QA Management ensures the following: Maintenance of the clinical and commercial Health Products Regulatory Authority (HPRA) manufacturing licenses Maintenance of Japan site accreditation and global GMP licenses Co-ordination of all country specific requirements received at JSI from internal and external affiliates e.g. pre-registration GMP requests (paper-based inspections) Management of Japan and China pre/post approval and periodic consistency checks to ensure the site processes are in compliance with the product filings Reviews change summaries for submission in the product Annual Reports, as required Supports pre-approval submissions for Cork products (e.g. reviews of the CTD sections for BLA/MAA) as required Supports post approval submissions for Cork products (e.g. reviews of the CTD sections, preparation of Type 1A, Type 1B, CBE30, PAS etc.) as required Co-ordination of Notarization and legalization management Maintenance of the Regulatory Playbook to ensure it is kept in line with current product workflows Attends site change control board meetings on a weekly basis with a particular focus to monitor change controls having impact to Japan site Accreditation Qualifications Pre-requisites: To be part of this high performing team you will have great attention to detail and have Bachelors Degree in a scientific/technical discipline required A minimum of 5 year’s experience in a quality, technical, analytical, validation or compliance role within the biological and/or pharmaceutical industry. Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.] Desirable but not essential: Post graduate qualification in Regulatory Affairs or other Previous experience working in Regulatory Affairs role Knowledgeable on regulatory systems such as ERIS, RIACS, GRAIL, RIMDocs, eCTD, etc. IMPORTANT This position description is a general guideline for colleagues; it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time, or to vary the duties and responsibilities of the position to meet production, scheduling, or other business needs. Primary Location Ireland-Cork-Cork- Organization Janssen R&D Ireland (7566) Job Function Quality Requisition ID 2206058659W