Quality Systems Manager External Biologics

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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.

Locations

IRL - Dublin - Baggot Street

Worker Type

Employee

Worker Sub-Type

Fixed Term (Fixed Term)

Time Type

Full time

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