Senior Quality Complaints Specialist
Share
Job Location:
Monthly Salary:
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
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 Takedas 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
Senior Quality Complaints Specialist (FTC 9 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:
Bachelors degree and 59 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.
Locations
IRL - Dublin - Baggot StreetWorker Type
EmployeeWorker Sub-Type
Fixed Term (Fixed Term)Time Type
Full timeRequired Experience:
Senior IC
Key Skills
About Company
Takeda is a patient-focused, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future.
