, for each other, and for the future of science, we’re in. Are you? About the Role: We’re looking for a GxP Clinical Systems IT Owner in the IT... of experience in IT/Clinical Systems Validation in Biotech/Pharma Industry. You are or you also have: Strong understanding of GxP...
, for each other, and for the future of science, we're in. Are you? About the Role: We're looking for a Sr Manager, IT Clinical Systems Validation... field along with 7 + of minimum years of experience in IT/Clinical Systems Validation in Biotech/Pharma Industry...
our SDLC policy. Clinical Systems Quality Manager will be responsible to ensure our clinical systems are developed, validated... System Owners the CSQM will oversee the quality and regulatory requirements of IT systems across Global Clinical Development...
more: . Position Summary: The Senior Manager, Benchtop IT Systems at the Devens Cell Therapy Facility is responsible for leading the..., Life Sciences, or related field. 7+ years of experience managing laboratory IT systems in a GMP or GxP-regulated...
with Business Owners and IT Infrastructure to ensure Enterprise class support is given to these business-critical systems. Partner... across data integration, mastering, and management for all systems within the clinical portfolio. Perform system configuration...
and modest costs. Description of Role Centessa is seeking a (Sr.) Manager, Clinical Supply Chain to oversee end-to-end... and ensure successful trial execution. Key responsibilities include managing clinical forecasts, inventory systems, and IRT tools...
Payrate: $40.00 - $42.00/hr. Summary: This Contract Manager, Clinical Supply Chain (DSCL Support Role) will provide... Product Introduction (NPI) processes, SAP workflow management, and continuous improvement initiatives. It offers the...
procedures and GxP requirements. Responsible for supporting and/or managing complex studies requiring Clinical Supplies project... Management systems Strong working knowledge of FDA clinical trial material requirements for IND’s and NDA’s as well as European...
This is what you will do: As Manager R&D IT, you will be a member of the R&D IT team reporting directly to the Sr.... Director of R&D IT that has accountability to Alexion's Heads of Research and Development functions. As Manager...
and cooperate with network engineers, systems engineers, solution architects, IT Security and/or Implementation Managers.... Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing...
that support both current operations and future roadmap innovation. This IT lead will play a key role in ensuring systems... Responsibilities: Lead the selection, implementation, and ongoing operations of IT systems supporting Madrigal's R&D landscape. Build...
in Pleasanton with proximity to the thriving Bay Area biotech corridor, you'll work on cutting-edge systems while ensuring rigorous... to categorize systems and determine appropriate validation rigor Validate diverse systems including cloud-based SaaS platforms...
will also flex it’s product manager skills to product management of our FileMaker Pro databases on our FileMaker Pro Platform... Analysis) and/or ITIL Foundation are a nice to have Experience in FDA 21 CFR Part 11, IT SOX, and GxP-regulated environments...
. The manager ensures randomization, treatment assignment, and clinical-supply workflows are compliant, reliable..., Biostatistics, Regulatory, Quality, and IT to deliver high quality systems that support complex trial designs and global regulatory...
, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope... more: . Position Summary The Manager, Quality Engineering at the Cell Therapy Facility (CTF) in Devens, MA will be responsible...
. Job Summary: The Manager, Strategic Contracting Operations serves as a Life Sciences–focused contracting leader, partnering.... Systems, Documentation & Operational Excellence Meet agreed-upon SLAs on turnaround times, and set appropriate expectations...
, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope..., and iCertis systems. Develop and maintain dashboards, KPIs, and reporting tools to monitor financial performance, operational...
teams. · Experience on systems supporting multi-product, multi-regions scheduling would be a plus. · Experience on GxP..., and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope...
, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope.... Required Competencies: Knowledge, Skills, and Abilities Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11...
and interpretation of cGMP Intermediate understanding of site quality GxP systems supporting document management, change controls..., and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope...