Quality Complaints Manager (FTC 31.12.2026)
応募 後で応募 求人ID R0166824 掲載日 11/19/2025 Location:Dublin, IrelandBy 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 and Terms of Use. 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
Quality Complaints Manager (FTC 31.12.2026)
You will be responsible for writing, investigating and approving product quality complaints 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 Takeda’s Global Quality road map.
How you will contribute:
Serve as the primary contact for product complaints and post-market surveillance.
Initiate, investigate, and manage product complaints through to closure using established systems and procedures.
Coordinate complaint investigations and ensure timely, thorough resolution—including escalation for regulatory notifications if needed.
Assess impacts of complaints on patient safety and product quality compliance.
Collaborate with internal departments and external stakeholders (e.g., CMOs, vendors) on complaint issues.
Prepare required documentation, such as customer response letters and monthly surveillance reports.
Act as a Subject Matter Expert (SME) during inspections, maintain training programs, and drive continuous process improvement.
In this position you will report to the Complaints Lead.
What you bring to Takeda:
Bachelor’s degree with 8-9 years’ experience in Quality Assurance or GMP-related fields in medical device, biotech, or pharma manufacturing.
Strong working knowledge of cGMPs and regulatory requirements for combination drugs and device products (EU/FDA).
Proven experience in product complaints handling, deviation management, CAPAs, compliance investigations, risk management, and cGMP audits.
Solid understanding of manufacturing processes for combination products and their link to customer complaints.
Excellent attention to detail, organizational skills, and systematic, risk-based approach to prioritizing and solving complex issues.
Demonstrated troubleshooting, problem-solving, and report-writing skills (e.g., investigation summaries, complaint responses).
Ability to work independently and as an effective team member or leader, building strong relationships across functions and with external partners.
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
Employee Stock Purchase Plan
Revenue approved profit share scheme
Humanitarian volunteering leave options
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.