External Supply Quality Manager, SM&O External Operations EU

Job title:

External Supply Quality Manager, SM&O External Operations EU

Company

Takeda

Job description

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 Takeda’s and . I further attest that all information I submit in my employment application is true to the best of my knowledge.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 an External Supply Quality Manager, SM&O External Operations EU.Takeda’s presence in Ireland was established in 1997 and our Irish operations have played a key role in our global leadership in rare diseases, oncology and gastroenterology. Since beginning commercial operations, Takeda Ireland has grown in strength thanks to substantial investment in our people and industry-leading technology.This position has responsibility for Quality Assurance, and support of Quality Control, for the Small Molecule and Oncology Contract Manufacturing Organizations (CMOs), Suppliers, and Contract Testing Laboratories (CTLs) located within the European region, inclusive of Drug Product, QC testing, packaging, and labelling activities.The External Supply Quality Manager is responsible for the Quality oversight of a portfolio of Contract Manufactures and associated products. The position requires interaction with numerous functions within the Small Molecule and Oncology Operating Unit, External Operations (SM&O ExOps), and other External Supply regions, with Takeda manufacturing sites, Takeda Local Operating Companies (LOCs), and external partners.You will report to the Head of QA Operations, SM&O External Operations EU.How you will contribute:Product Quality Oversight: Responsible for product quality performance at CMOs/Suppliers, ensuring compliance and identifying quality risks aligned with standards and Takeda Global Quality Standards.Quality Agreements Management: Prepare, approve, and maintain Quality Agreements with relevant CMOs/Suppliers.Quality Risk Management: Oversee quality performance through risk management, deviation reviews, change management, and KPI evaluations.Compliance Strategy Support: Support and implement compliance strategies and quality programs for Takeda outsourced manufacturing/packaging operations.Decision Making: Represent Takeda to decide on the acceptability of quality programs and activities at CMOs/Suppliers.Incident Management: Comply with Quality Incident Management processes, issue notifications, and prepare for Quality Alignment Meetings.Quality Expectations: Establish and support quality and compliance expectations for CMOs/Suppliers and perform strategic reviews.Regulatory Compliance: Work with Takeda LOCs to ensure compliance with country-specific manufacturing/packaging regulations.Audit and Oversight: Lead/support audits of CMOs/Suppliers, prepare audit reports, and review corrective actions.Regulatory Awareness and Support: Maintain awareness of legislation, update supplier management programs for compliance, and support product submissions and launches.What you bring to Takeda:Minimum of Bachelor’s Degree in Pharmacy, Chemistry, Biology or related discipline and minimum of 5 years of QA/QC experience in the pharmaceutical industry and/or QA/QC laboratory environment. Project Management expertise desirable.Experience of cGMPs, ICH and other relevant regulations. A broad based knowledge of domestic, and general knowledge of international regulations associated with manufacturing and packaging.Familiar with Common Technical Documents (registration files).Analytical Skills – ability to thoughtfully analyze a wide variety of information and data to make key decisions regarding potential risks associated with product quality or regulatory violations, and anticipate potential problems and risks related to commercial product operations, investigate solutions, and implement preventive actions.Fluent in written and spoken English and experience with Microsoft 360 Package.What Takeda can offer you:Competitive salary and performance-based bonusEmployer retirement plan contributionsEmployee Stock Purchase PlanRevenue approved profit share schemeEmployer funded income protectionEmployer funded private medical insurance with dependents’ coverEmployer life insurance contributionsElectric charging points available at parking locationsEmployee Assistance ProgramWellbeing and engagement teamsTakeda Resource GroupsFlexible working arrangementsFamily friendly policies26 vacation days plus additional days for service milestonesCoaching and mentoringEducational programs and formal trainingDevelopment opportunitiesHumanitarian volunteering leave optionsFlexible employee funded options like Dental Insurance, Partner Life Insurance, Serious Illness Protection, Fuel Card, Bike to Work, Commuter Ticket, and Insurance DealsMore 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 two 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 StreetZurich, SwitzerlandWorker Type EmployeeWorker Sub-Type RegularTime Type Full time

Expected salary

Location

Dublin

Job date

Wed, 05 Feb 2025 23:22:07 GMT

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