By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice (https://jobs.takeda.com/privacynotice) and Terms of Use (https://www.takeda.com/terms-and-conditions/) . I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** Are you looking for a patient-oriented, innovation-driven company that inspires you and promotes your career? Then take your future in your hands and become part of Takeda as a **Complaints Lead USA.** **About the role:** Reporting to the Head of Market Surveillance, you are responsible for leading and managing the USA Based product complaints team and all related activities associated with the complaint handling program at Takeda per corporate procedure and regulatory standards including goal setting in-line with corporate strategy and priorities and the GQ road map. + Hybrid role located in our **_Baggot Street office_** + Limited contract until **_March 31st 2027_** . **How** **you will** **contribute:** + Leading a team of complaint specialists/manager (located in Lexington, USA) in the management of complaints + Serve as point of contact for commercial product complaints and post market product vigilant monitoring processes + Receive, process, initiate and approve product complaint investigations using the current product complaints management software and coordinate all aspects of investigation through closure and/or provide oversight for complaint handling process. + Apply departmental procedures to assess product complaints' impact on patient safety and product quality compliance. + Assess product complaints and determine if escalation is required due to potential regulatory notification requirements. + Interface and collaborate with various departments including the OpUs, External Supply, Quality Assurance, Regulatory, Development, Safety/Pharmacovigilance, etc and the regional organisation. Interface with external stakeholders such as CMO, Call Centers and vendors/contractors on product complaint issues. + Point of contact for vendor – Intake center for US complaints + Assure that all product complaints are investigated to the appropriate level within the required timeline. + Critically review and approve complaint investigations + Represent Takeda as the Subject Matter Expert (SME) for the product complaints process during Internal, External and Regulatory Body Inspections. + Drive continuous Improvement **What you bring to Takeda:** + Bachelor's degree with a minimum of 12 years of experience in Quality Assurance or a GMP related field within Medical device, biotechnology or pharmaceutical manufacturing, or equivalent. + Working knowledge of cGMPs and other regulatory requirements governing combination drugs and device products. + Knowledge of EU/ FDA cGMP requirements pertaining to drug/device product complaints reporting and investigation. + Experience in managing team members to achieve high performance, while supporting their professional development and growth + Desirable experiences: combination working experiences in product complaints handling, deviation management, CAPAs, quality compliance investigations, risk management, and cGMP audits. + Good understanding of the manufacture of combination products and the linkage to customer complaints. **What Takeda can offer you:** + Competitive salary and performance-based bonus, + Employer retirement plan contributions, + Employer funded income protection, + Employer funded private medical insurance with dependents' cover, + Employer life insurance contributions, + Electric charging points available at parking locations, + Employee Assistance Program, + Wellbeing and engagement teams, + Takeda Resource Groups, + Flexible working arrangements, e.g., hybrid or shiftwork with shift allowance, + Family friendly policies, + Humanitarian volunteering leave options, + On-Site Gym, + Flexible employee funded options like Dental Insurance, Partner Life Insurance, Serious Illness Protection, Fuel Card, Bike to Work, Commuter Ticket, and Insurance Deals. **More about us:** Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines. Takeda Ireland was established in 1997. Our story in Ireland is one of substantial growth, rapid change, and innovation. Over the past two years, Takeda Ireland has invested over €55 million in Ireland to develop our manufacturing sites. Solidifying our commitment in our people and contributing to the local economy. Takeda in Ireland has commercial operations, corporate services, and manufacturing facilities across four locations: Baggot St, Bray, Citywest, and Grange Castle. We have been certified as Top Employer for several consecutive years. **How** **we will** **support you:** Takeda is proud of its commitment to create a diverse workforce and to provide equal employment opportunities to all employees and applicants for employment without regard to ethnicity, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status or any other characteristic protected by law. If you are living with disabilities, chronic illness, or neurodiversity, please feel free to let us know so that we can provide you with appropriate support during the application process. **Locations** IRL - Dublin - Baggot Street **Worker Type** Employee **Worker Sub-Type** Fixed Term (Fixed Term) **Time Type** Full time