Quality Compliance Manager

Description About the role:This is a management position in an ethical Solid Oral Dosage Pharmaceutical Formulationand Finished Product plant. The brief requires a thorough knowledge of Good ManufacturingPractice, current FDA & EMEA regulations for solid oral dosage pharmaceuticals for humanuse and a good working knowledge of manufacturing processes, packaging processes andvalidation activities used in the pharmaceutical industry. Good organizational, supervisory,technical writing and investigation skills are required.How you will contribute:Act as the formal contact point with the HRPA, the FDA and other Regulatory Authorities.Promote a culture of Compliance, Right First Time and Continuous Improvement.Implementing efficiency improvements in Quality and participating in site projects and initiatives.Management and oversight of site Regulatory Compliance and oversee the Contract Manufacturing Business Quality activities for the site.Inspection Management: Prepare and present the Company for both immediate and routine Regulatory Inspections. In addition, you may be involved in attending at or conducting overseas facility inspections. Manage and maintain site self-inspection program.Oversight of Annual Product Quality Reviews.Quality data management in SAP and XFP (MES).Management of customer, supplier and service agreements.Oversight of GMP processes (Pest control, contamination control, facility/utility monitoring/requalification etc.).Oversight of GxP processes (system data integrity, periodic and backup reviews).Support the site Quality Management systems including the Deviation and CAPA Management systems, Change Control system, GMP Training and the Vendor Management program.Oversight of validation lifecycle, including documents and associated deviations/NCRs for equipment, facility, utility, process, cleaning & computerized systems in line with current industry regulations and guidelines.Oversight of Quality risk Management program at siteActing as a designee to the Site Quality Head as required.General Responsibilities:Drive and promote the corporate values of Takeda-ism within the workplace. Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.Drive and maintain staff development.Drive and Maintain Department KPIs.Drive and support site must win battles.Other duties as required and directed by the Site Quality Head, or other Officer appointed by the Board of Directors.What you bring to Takeda:Degree in Science or other relevant field.QP Qualification desirable but not necessary.At least 3 years’ experience working in a Quality or Engineering Management role in a regulated environment.Experience in audit management (HPRA, FDA, Corporate and Clients).Previous experience in Lean Management is preferable.Good knowledge of Pharmaceutical Production & Packaging processes.Solid Oral Dosage processing experience is highly desirable.Good knowledge of GMP, validation regulations and guidelines is highly desirable.A strong technical understanding of processes, equipment and computer systems is advantageous.Experience in data integrity practices would be an advantage.Qualified Person status is desirable but not essential.What Takeda can offer you:Great compensation package and performance-based bonusEmployer retirement plan contributionsEmployee Stock Purchase PlanRevenue approved profit share schemeEmployer funded income protectionEmployer funded private medical insurance with dependants' coverEmployer life insurance contributionsElectric charging points available at parking locationsEmployee Assistance ProgramWellbeing and engagement teamsTakeda Resource GroupsFlexible schedule, e.g., hybrid or shiftwork with shift allowanceFamily friendly policies26 vacation days plus additional days for service milestonesEducational programs and formal trainingDevelopment opportunitiesHumanitarian volunteering leave optionsSubsidized canteenFlexible 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 departments, 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. 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, colour, 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.LocationsBray, IrelandWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time