Head of Quality Control (QC), Cell Therapy Facility - Grange Castle

Company: Takeda Pharmaceutical
Location: Dublin
Posted on: June 18, 2022

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 Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the role:The Head of Quality Control manages the Quality Control laboratories for Cell therapy medicinal products manufactured at the P3 Cell therapy manufacturing facility in Takeda Ireland Ltd, Grange Castle. The QC Laboratory Manager has responsibility for both the QC testing and Microbiological testing activities for the Cell Therapy manufacturing facility .The Head of Quality Control will work closely with other Quality Department personnel as part of the site Quality Department. The Head of Quality Control may assume responsibilities in any of the Quality Department pillars, following our needs.As with all site personnel, the Head of Quality Control promotes a culture of Regulatory Compliance and Continuous Improvement within the Quality Control and across the Cell Therapy manufacturing plant and the TILGC site.How you will contribute:

• Management of the Quality Control(Cell Therapy) team ensuring that QC laboratories operating in compliance with current Good Laboratory Practice / Good Manufacturing Practice.
• Maintain standards of GLP and analytical practice consistent with current regulatory expectations and Global Takeda standards.
• Manage real-time review of QC data and trends associated with materials release and batch disposition associated with the Cell Therapy product. (The management of these activities will take place on a shift rota and the future state may be asked to take place 24/7).
• Manage laboratory resources (instruments and personnel) to provide a service for testing of all QC and microbiological samples ensuring that personnel is trained all tasks within the laboratories and recruitment of experienced personnel.
• Management of testing schedules adherence to support the release of material to support manufacturing and disposition of the final product.
• Communication and liaison with other Cell Therapy and TILGC departments on Quality Control issues, providing guidance to others.
• Manage investigations related to QC following the site Deviation Management System, ensuring root cause analysis and assigning of CAPAs.
• Manage the Change Control process for QC, ensuring controlled implementation of changes.
• Ensure participation of the QC (Cell Therapy) team in production and other site meetings.
• Manage Key Performance Indicators within the Quality Control area to ensure adherence to local and global quality KPIs .
• Participation in the Internal Audit programme.
• Participation in the preparation of, and represent the QC Department, external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
• Manage Inspection readiness and close out of gaps identified for QC in the Inspection readiness assessment and Site Inspection Success Rating (SSIR).
• Manage Method Transfers/Validation, associated with Tech Transfers to and from the Cell Therapy Manufacturing Facility Lead ensuring key milestones are achieved.
• Participation in the preparation of QC related documentation for regulatory submission and participation in regulatory affairs discussions associated with QC.
• Take a leadership role in promoting a culture of Compliance, Right First Time and Continuous Improvement from both Quality and Safety.
• Implement efficiency improvements in QC Department on a continuous basis and participating in site projects and Global Quality plans. Lead major projects, quality initiatives and continuous improvement programmes within the Quality Control department.
• Implementation LIMS - ensuring usage within the laboratory is improve. Maintain standards of safety and good housekeeping to provide a safe working laboratory.
• Create and the management of QC annual budget for consumables, capital and headcount.
• Participate in global project teams relating to QC and wider quality activities.
• Report to the Head of Quality for Cell Therapy.GENERAL RESPONSIBILITIES:Participate in any cross functional training plans.Guide and promote the corporate values of Takeda-ism within the workplace.Foster, in cooperation with other staff, an ethos and culture of safety awareness where safety is accepted as an important part of the business. Ensure that Accident Reports / Near Miss Forms are completed on time after an event.Development of the QC teamWhat you bring to Takeda:
  • Degree in Science or other relevant field.
  • More than 10 years' experience in the pharmaceutical/Biopharma industry and minimum of 5 years QC Laboratory Management experience
  • Experience in Cell Therapy product testing would be advantageous
  • Experience of both chemistry and microbiological testing
  • Experience in budgetary control and audit preparation
  • Knowledge of GMP and current FDA & EMEA regulations
  • Experience managing the performance of individual team members and that of the overall team
  • Knowledge of Lean Laboratories is preferable
  • Experience setting up a new QC laboratory is desirable
    SKILLS/COMPETENCIES:
    • Excellent knowledge of Good Manufacturing Practice for aseptic pharmaceutical manufacture as described in current FDA & EMA regulations.
    • Experience managing and motivating a team.
    • Project management skills.
    • Knowledge in HPLC and Flow cytometry
      What Takeda can offer you:
      • Excellent conditions and benefits
      • Genuine career progression and development
      • Opportunity to work with an excellent leader in the pharmaceutical sector
      • Professional development opportunitiesMore about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Empowering our people to shine:Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, 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.LocationsGrange Castle, IrelandWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

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