- This position is Computerized System owner and responsible for Design, Configuration, and Continuous Improvement of the global system. Primary IT application – global Laboratory Management System (Labware)
- This position is responsible for QA oversight of the Takeda GxP related application, and established IT procedures. This position will contribute to improving systems/applications quality by appropriately monitoring processes and providing recommendations for improvement opportunities for any given area of IT.
- The position will contribute to the activities such validation, change control, handling or supporting investigation of deviation as well as provide Quality oversight and/or Quality approvals for GxP systems.
- Accountable for contributions to the project delivery by performing project and IT application - applicable Quality Compliance support in a global environment and ensuring that the product developed meets the defined user and quality compliance requirements.
- Responsible for assuring, in association with the TSO (Technical System Owner), that a system/application meets its requirements and is compliant with applicable Takeda QMS, and the documentation set outlined in the Validation Plan for the project. Review project team deliverables to ensure quality (design walk-through, test results, etc.) and adherence to standards/ regulatory requirements. Supports TSO in all GxP regulations, compliance with internal and external procedures, and all aspects of the safe, reliable, and consistent operation of the computerized system.
- Defines/agrees on the GxP IT systems deployment strategies for validation efforts based on risk-based approach, including the development of project plans required for the deployment of such systems. Manages and coordinates and provides review and approval for the development and execution of validation protocols, data analysis and development of final reports.
- Global Quality ownership of the LIMs application workflow
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS
- BS in science or engineering
- 5+ years of knowledge and experience in bio-pharmaceutical technology
- Knowledge of LIMS, Labware or similar application is preferred
- Experience must include managing global change by influence – without direct resource control;
- Strong focus on delivering global results as well as building site capability to demonstrate effective governance
- Fluent in written and spoken English.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.