- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of successful Health Authority inspections and approvals - Proactively partner and lead the strategic collaboration with other GxP Quality representatives, and ... act as the Quality Assurance point person for all GxP matters within the Medical Affairs team and with...throughout the clinical trial process. Customer Focus / Stakeholder:Engagement Lead the implementation of the quality strategy… more
- Repligen (Waltham, MA)
- …is seeking a hands-on, strategic Director of IT & OT Infrastructure to lead the design, implementation , and ongoing optimization of our global technology ... MSPs, and vendors to ensure high-quality, secure, and reliable services.You will lead and develop a high-performing team, drive continuous improvement, and ensure… more
- BioAgilytix (San Diego, CA)
- …and evaluating results. Identify new analytical techniques and technologies and lead their implementation .Review analytical instrument and equipment calibration, ... We are tirelessly committed to our customers by being solution -oriented and deadline-driven. . . and we are growing....to the patients who need them.The Manager II will lead scientific and operational activities in support of preclinical,… more
- Insmed Incorporated (San Diego, CA)
- …and for the future of science, we're in. Are you?About the Role: \tEngage on GxP Projects as a key team member. \tProvide guidance and support to ensure Insmed ... making on CSV strategy Develop risk-based validation strategies for system implementation and changes following CSV SOPs and Work Instructions Coordinate all… more
- Insmed Incorporated (NJ)
- …limited to the following: Develop risk-based validation strategies for system implementation and changes following CSV SOPs and Work Instructions Coordinate all ... oversight in the IT Change Control processes (both in ServiceNow and the GxP IT CAB process) Who You Are: Position Requirements (Required and/or Preferred Skills,… more
- BeOne Medicines (Emeryville, CA)
- …implementing industry best practice processes across the organization. This role will lead an end-to-end risk management process to drive in-time risk mitigation and ... but not limited to SOX, US DoJ Data Rule, GxP , ISO, NIST CSF, and other relevant data security...and other stakeholders in NA&LATAM region to implement new solutions and processes as well as document and remediate… more
- Endo International (St. Louis, MO)
- …everyone we serve live their best life. **Job Description Summary** The Lead Validation Engineer will create, review and/or execute primary qualification and ... product quality and site compliance to regulatory requirements. The Lead Validation Engineer interfaces with Manufacturing, Quality Assurance, Quality Control,… more
- Terumo Medical Corporation (Somerset, NJ)
- …Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions -based portfolio of high-quality medical devices used in a broad range ... as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients. **Join us and help shape wherever we go next!**… more
- BeOne Medicines (Pennington, NJ)
- …Automation Engineering is responsible for leading the strategy, development and implementation of automation technologies and digital solutions across ... Future initiatives at the site. Partner with Global Technology solutions to ensure right fit for manufacturing. + Project...culture, purification, filling, packaging and OSD. + Participate and lead in controls fault or process fault analysis and… more
- Sanofi Group (Swiftwater, PA)
- **Job Title:** Solution Implementation Lead **Location:** Swiftwater, PA **About the Job** We deliver 4.3 billion healthcare solutions to people every ... bring hope to patients and their families. The Local Solution Implementation Lead is responsible... Lead is responsible for Swiftwater site implementation of global Smart Factory solutions that… more
- Sanofi Group (Swiftwater, PA)
- …pain points to the global team. + Drive business activities related to solution implementation initiatives + Business Value Projects + Major and Minor ... site implementation , lifecycle, and compliance with global Smart Factory solutions that support Manufacturing & Supply operations. This role reports to the… more
- Cognizant (Dallas, TX)
- …an experienced **Manhattan Active Warehouse Management Systems (MAWM) Solution Lead ** to drive end-to-end design, configuration, and implementation of MAWM ... Manhattan Active WMS Solution Lead **About the Role** We...business requirements and translate them into technical specifications. + Lead design, configuration, implementation , and support of… more
- Sanofi Group (Morristown, NJ)
- …to get started? **Main Responsibilities** + Lead and oversee the design and implementation of all solutions for Digital In Silico Research & CMC operations. ... to define the high-level vision and roadmaps in terms of solutions architectures, ensure proper implementation , maintaining interoperability and consistency… more
- Cognizant (Bridgewater, NJ)
- …Architect, you will make an impact by leading the design and implementation of comprehensive cutting-edge solutions that deliver best-in-class patient ... **Salesforce CRM Solution Architect** **Job Overview:** As a Salesforce CRM...and enterprise architects. **In this role, you will:** - Lead the design and implementation of Salesforce… more
- NTT America, Inc. (Pittsburgh, PA)
- …and forward-thinking organization, apply now. We are currently seeking a Testing & Validation Lead - SAP ECC Implementation (remote) to join our team in ... (US). We are currently seeking a **Testing & Validation Lead - SAP ECC Implementation Project** to...standards (eg, FDA 21 CFR Part 11, SOX, or GxP requirements where applicable). + Maintain and review validation… more
- NTT DATA North America (Dallas, TX)
- …strategy. NTT DATA Services Client currently seeks a Testing & Validation Lead to be responsible for defining, planning, and executing the end-to-end testing ... and validation strategy for an enterprise-wide SAP ECC implementation project. This role ensures that all system components,...and compliance requirements before go-live. The Testing and Validation Lead will lead a cross-functional team of… more
- Lilly (Indianapolis, IN)
- …support growth across new sites, modalities, and partnerships Modernization of solution infrastructure through cloud-based platforms and advanced technologies As a ... ** Solution Architect - Integration** , you will play a...You will define and guide the architecture for integration solutions , ensuring they are scalable, secure, and aligned with… more
- Sanofi Group (Cambridge, MA)
- …of Solutions Engineering (a Technology Principle) to make it happen. You'll lead a specialized team of 5-7 solution engineers while partnering directly with ... **Job Title:** Head of Solutions Engineering **Location** : Cambridge, MA, Morristown, NJ...This isn't a traditional technology role. You'll build and lead a cross-functional team with full hiring authority while… more
- System One (Princeton, NJ)
- Lead Validation Specialist Location: Remote (Preference for East Coast candidates) Salary: $125,000-$150,000/year + bonus potential About the Role We're seeking an ... experienced Lead Validation Specialist with a strong background in clinical...initiatives to ensure that all systems are compliant with GxP regulations and 21 CFR Part 11, working closely… more
- Gilead Sciences, Inc. (Foster City, CA)
- …President to lead the next phase of our enterprise-wide SAP implementation program. This role is critical to driving digital transformation across our global ... Chief Information Officer and be located in Foster City, California. It will lead a geographically dispersed team of dedicated and matrixed internal business, IT and… more
