Senior Quality Complaints Specialist (FTC 8 months)
Takeda
IRL - Dublin - Baggot Street, Unknown
Full-Time
Competitive
HybridSenior
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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
Senior Quality Complaints Specialist (FTC 8 months)
You will have a direct impact on patient safety, product quality, and regulatory compliance, delivering meaningful work that is highly visible across the organization. This role offers you broad cross-functional exposure, ownership of complex investigations, and the opportunity to act as a subject matter expert while driving continuous improvement.
How you will contribute:
Manage product quality complaints end-to-end, from intake and initiation through investigation, approval, and closure.
Ensure complaint handling is compliant with Takeda procedures and applicable regulatory and quality standards, including EU, FDA, and ISO 13485 requirements.
Assess complaints for patient safety, product quality, and regulatory impact, including determining when escalation or regulatory notification is required.
Coordinate cross-functional investigations with internal teams and external partners such as QA, Regulatory, Pharmacovigilance, OpUs, CMOs, call centers, and vendors.
Oversee timely completion of complaint investigations and support complaint governance activities to ensure closure within required timelines.
Act as the quality SME and primary point of contact for commercial product complaints, post-market vigilance monitoring, and inspection support.
Drive continuous improvement of complaint handling processes to maintain lean, effective, and compliant operations.
In this position you will report to the Complaints Lead.
What you bring to Takeda:
Bachelor’s degree and 5–9 years of experience in Quality Assurance or a GMP-related role in medical device, biotechnology, or pharmaceutical manufacturing, or equivalent.
Strong knowledge of cGMP and applicable regulatory requirements, especially for combination drug/device products.
Understanding of EU and FDA requirements for product complaint reporting and investigation.
Relevant experience in complaint handling and quality investigations, including areas such as deviations, CAPAs, risk management, and compliance investigations.
Good understanding of combination product manufacturing and how manufacturing issues connect to customer complaints.
Strong investigation, troubleshooting, and problem-solving skills, with the ability to write clear investigation summaries, reports, and complaint responses.
Highly organized and able to work independently and cross-functionally, with a structured, risk-based approach to prioritization and collaboration.
What we can offer you:
Employer funded private medical insurance with dependants’ cover
Competitive salary and performance-based bonus
Employer retirement plan contributions
Flexible working arrangements, e.g., hybrid work
26 vacation days plus additional days for service milestones
Family friendly policies
Employee Assistance Program
Wellbeing and engagement teams
Employer life insurance contributions
Development opportunities
Educational programs and formal training
Coaching and mentoring
Employer funded income protection
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
Electric charging points available at parking locations
Takeda Resource Groups
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 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.
Base Salary Range:
€57,800.00 - €79,420.00For information about our benefits, please click here.