Quality Compliance Lead – External Biologics – Takeda
Location: Dublin, Baggot Street
Company: Takeda Pharmaceutical
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Responsibilities
Lead External Biologics regulatory inspections at Takeda Ireland (HPRA & Russian MIT) and manage inspection readiness, support, and remediation across CMOs and CTLs.
Lead and maintain the Takeda Baggot Street Site Master File (SMF) and the Product Quality Review process for external biologic products.
Lead the External Biologics internal audits, self‑inspection program, and compliance risk assessments.
Maintain knowledge of current applicable global regulatory requirements and apply cGMPs daily to ensure operational compliance.
Manage day‑to‑day operations independently, providing strategic oversight, problem resolution, and risk mitigation.
Partner with senior management on critical compliance issues.
Participate in and lead continuous‑improvement projects to enhance compliance and quality systems, supporting MAH activities for Takeda Pharmaceutical International – Ireland Branch.
Report to the Head of Quality Systems and Compliance – Biologics OpU Quality – External Manufacturing.
Qualifications
Bachelor's or advanced degree in a relevant scientific or technical discipline with minimum 8 years' experience in quality systems and compliance in biologics or sterile manufacturing.
Proven leadership experience managing quality or technical teams in a global biopharmaceutical setting.
Strong understanding of cGMP, GLP, ICH guidelines, FDA CMC expectations, and related international standards.
Demonstrated knowledge of biologics and aseptic manufacturing processes, systems, and technologies.
Experience interacting with regulatory agencies and leading site or external partner inspections.
Ability to influence, collaborate, and communicate effectively across internal and external stakeholders with strong analytical, risk assessment, and decision‑making skills.
Commitment to Takeda's values – Patient, Trust, Reputation, and Business‑driving quality excellence.
Benefits
Employer‑funded private medical insurance with dependants’ cover
Competitive salary and performance‑based bonus
Employer retirement plan contributions
Flexible working arrangements
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 such as dental, partner life, serious illness protection, fuel card, bike‑to‑work, commuter ticket, and insurance deals
Electric charging points at parking locations
Takeda Resource Groups
About Takeda
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. We have invested over €55 m in Ireland to develop our manufacturing sites. 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.
Our Commitment to Diversity & Inclusion
We provide equal employment opportunities to all employees and applicants without regard to protected characteristics. If you are living with disabilities, chronic illness, or neurodiversity, please let us know so we can provide appropriate support during the application process.
Quality Control Student – Takeda
Location: Grange Castle, Ireland
Responsibilities
Apply knowledge of analytical techniques (HPLC, GC, wet chemistry) to perform accurate testing of samples and materials.
Participate in calibration and maintenance of laboratory equipment.
Support a safe, clean, and efficient laboratory environment by adhering to 5S practices and safety procedures.
Engage in cross‑functional training and contribute to QC improvement projects.
Demonstrate strong organizational, communication, and report writing abilities.
Champion Takeda‑ism values every day.
Qualifications
Solid foundational knowledge in analytical techniques, including HPLC, GC, and wet chemistry.
Practical experience handling laboratory tasks and equipment, demonstrating attention to detail and compliance with quality standards.
Strong organizational skills and ability to manage multiple priorities.
Effective communication and interpersonal abilities.
Proficiency with Microsoft Office and digital tools.
Benefits
Flexible working arrangements
26 vacation days plus additional days for service milestones
Employee Assistance Program
Wellbeing and engagement teams
Coaching and mentoring
Humanitarian volunteering leave options
Subsidized canteen
Electric charging points at parking locations
Quality Assurance Engineer (French) – Alexa Global Quality
Locations: Dublin, London, Madrid
Responsibilities
Own everyday product quality for your workstream.
Collaborate with engineering and product teams to deliver high‑quality product.
Monitor production trends and act to improve customer experience.
Evaluate device and Alexa functionality, create and own test strategies that are highly relevant to your customers.
Develop and contribute automation and quality tooling to improve test efficiency.
Raise, triage and bring defects to resolution to improve user experience worldwide.
Communicate with partners and stakeholders to report program status and develop processes and tools.
Use advanced French language skills to assist in French‑language products.
Qualifications
Experience developing high‑quality test plans, designs, strategies, and execution.
Experience working closely with development and business teams to communicate impacts.
Experience scripting or coding.
Experience troubleshooting and debugging technical systems.
Level C1–C2 French proficiency.
Preferred Qualifications
Experience with Android, iOS, or other mobile application testing.
Experience with Test Rail, TestLink, and Jira.
Experience as QA lead on medium‑to‑large projects.
Inside Plant Cabling Quality Assurance Engineer – AWS
Location: AWS Data Centers across North America and Europe
Responsibilities
Drive world‑class quality in the data center to achieve best operating cost.
Make quick decisions and conduct risk assessments.
Collaborate with engineering to establish global design standards and best‑practice guidelines.
Develop and manage quality manuals, audit strategies, and performance metrics.
Audit and inspect data center and edge sites, generate punch lists, and remediate plans.
Conduct training for local infra delivery teams.
Support new product implementation activities.
Travel >40% to review projects and coordinate onsite personnel.
Qualifications
Experience in quality assurance engineering.
Experience related to the design or construction of data centers or critical infrastructure.
Experience with project management and engineering collaboration.
Quality Compliance Supervisor – Grifols
Location: Ireland (Dublin / Grange Castle) – Regular Full‑Time
Responsibilities
Ensure quality compliance in albumin manufacturing, both purification / formulation and aseptically filled products.
Manage team scheduling to support day‑to‑day manufacturing operations, product release, and business requirements.
Oversee trial and compliance risk assessments and mitigation.
Support cross‑functional readiness for batch certification and documentation.
Maintain compliance with GMP, EU Annex 1, FDA, and other regulatory guidelines.
Provide team performance status and KPI tracking.
Develop internal and external SOPs, training, and records.
Conduct periodic audits, internal inspections, and Gemba walk‑throughs.
Qualifications – Essential
Working experience within a sterile pharmaceutical GMP‑regulated industry with a quality function.
Minimum 5 years of experience in a pharmaceutical quality environment under EU GMP regulation.
Experience with QMS processes, both paper‑based and electronic (Veeva Vault, Trackwise).
Experience with deviations, investigations, and CAPAs of all classifications.
Experience with people management (stakeholder or direct).
Problem‑solving mindset and strong working ethic.
Project management skills for multiple high‑priority tasks.
Excellent verbal and written communication in English.
Proficiency in Microsoft software.
Qualifications – Desirable
Knowledge of albumin manufacture and aerosol filling.
Experience with cleanroom classifications and RABS technology.
Experience with SAP or LIMS.
Experience managing at least two people.
Spanish / Catalan proficiency.
Bachelor or Master’s degree in pharmaceutical sciences.
Benefits
Highly competitive salary.
Group pension scheme with company matching.
Private medical insurance.
Career development opportunities.
Succession planning and internal promotions.
Education allowance.
Wellness and social activities (e.g., padel, summer events).
Global Commitment to Diversity & Inclusion
We are committed to equal employment opportunities and to providing support for applicants living with disabilities, chronic illness, or neurodiversity.
Additional Information
Feel free to join an international team working to improve the future of healthcare. Grifols is a global healthcare company focused on plasma‑derived medicines.
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