Quality Compliance Lead

Job DescriptionAre 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 aQuality Compliance Lead - External BiologicsBased at Takeda's Baggot Street site, you will spearhead inspection readiness and compliance across CMOs and CTLs.Acting as the vital link between Global Quality Compliance and External Biologics, you will play a key role in safeguarding product quality and ensuring patient safety—making a real impact across Takeda's External Biologics supply.How You Will ContributeLead 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 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.Routinely 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.In this position you will report to the Head of Quality Systems and Compliance Biologics OpU Quality - External Manufacturing.What You Bring to TakedaBachelor'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 regulations, 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 across all activities.What we can offer youEmployer funded private medical insurance with dependants' coverCompetitive salary and performance-based bonusEmployer retirement plan contributionsFlexible working arrangements26 vacation days plus additional days for service milestonesFamily friendly policiesEmployee Assistance ProgramWellbeing and engagement teamsEmployer life insurance contributionsDevelopment opportunitiesEducational programs and formal trainingCoaching and mentoringEmployee Stock Purchase PlanRevenue approved profit share schemeHumanitarian volunteering leave optionsEmployer funded income protectionOn-Site GymFlexible employee funded options like Dental Insurance, Partner Life Insurance, Serious Illness Protection, Fuel Card, Bike to Work, Commuter Ticket, and Insurance DealsElectric charging points available at parking locationsTakeda Resource GroupsAbout UsTakeda 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 ****.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 youTakeda 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.LocationIRL - Dublin - Baggot Street#J-*****-Ljbffr