Quality Systems Manager External Biologics (FTC 18.12.2026)
応募 後で応募 求人ID R0164974 掲載日 10/14/2025 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 Systems Manager External Biologics (FTC 18.12.2026)
You will manage and enhance Quality Systems for External Biologics, ensuring compliance with global and site requirements. This role serves as the Systems Execution Lead, driving system performance, leading audits, and ensuring timely closure of quality records. By overseeing key processes such as deviations, CAPAs, and product quality reviews, you will strengthen compliance, support continuous improvement, and advance Takeda’s commitment to quality and patient trust.
How you will contribute:
Manage and continuously improve Quality Systems for External Biologics in alignment with global Takeda standards and regulatory requirements.
Act as the primary liaison between Global Quality Systems and External Biologics sites to ensure consistent execution.
Provide subject matter expertise and support during audits, inspections, and regulatory engagements.
Lead key quality governance activities, including the Quality Council and performance metrics for External Biologics Supply.
Oversee Product Quality Review processes and ensure effective management of quality records such as deviations, CAPAs, and change controls.
Support the Health Products Regulatory Authority (HPRA) licenses.
Partner with senior management and cross-functional teams to resolve issues, mitigate risks, and lead continuous improvement projects.
In this position you will report to the Head of Quality Systems and Compliance.
What you bring to Takeda:
Degree in a scientific or technical discipline with substantial Quality Systems experience in biologics or sterile manufacturing, including managerial responsibilities.
Proven knowledge of Quality Management Systems such as TrackWise.
Strong understanding of patient, compliance, and business priorities within a regulated environment.
Experienced in operating within multinational organizations and aligning with diverse regional regulations.
Expert in GMP, validation, risk management, and change control, able to handle complex quality challenges and mentor others.
Skilled in technical documentation, project management, and automation initiatives, driving continuous improvement.
Demonstrated ability to guide cross-functional teams through complex quality processes and compliance strategies.
What Takeda 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
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 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.