- Aequor (San Diego, CA)
- …and analytical and process equipment computers for Gene Therapy operations. Ensure compliance with industry standards and GxP guidelines. Execute project in ... Expert Engineer - Automation/OT Hybrid San Diego site...SCADA systems o analytical and process equipment computers Ensure compliance with industrial standards and GMP guidelines Apply technical… more
- Eisai, Inc (Nutley, NJ)
- … compliance with regulatory, organizational, and commercial requirements.Define and execute IT compliance processes (data privacy, GxP , JSOX).Manage ... Controls Management Lead is responsible for overseeing the entire portfolio of IT Compliance responsibilities from both the strategic and execution perspectives… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Costing and Quality Inspection attributes. This role will partner with the IT team and collaborate in the design-implementation of Legend's Master Data Management ... Manufacturing network.Your role will involve collaborating with cross-functional business teams, IT and SAP Integration partners to define and optimize business… more
- Nestle (Brisbane, CA)
- …and communication. + Act as a subject matter expert for the IT GxP Compliance Program. + Partner with QA to manage systems validation, periodic ... + Support Clinical Operations, Biometrics, and data management systems to ensure IT GxP compliance . GxP System Operations: + Oversee application… more
- Schrodinger (Cambridge, MA)
- We are looking to hire a **Director, GxP Quality Assurance and Compliance ** to join us in our mission to discover and develop drugs that improve human health ... will love this job:** + A strategic subject matter expert who's ready to partner with cross-functional teams as...and clinical teams **What you will do:** + Overall GxP Responsibilities: + Design, develop and implement overall … more
- Fresenius Medical Center (Lexington, MA)
- …+ Understanding the method for the management of IT departments providing GxP system support/management + Responsible for compliance in alignment with the ... the IT department. This position is responsible for ensuring compliance with established processes, documentation, and controls to drive efficiency and quality… more
- Lilly (Indianapolis, IN)
- … Support** + Lead inspection readiness activities + Serve as a global compliance CGMP expert providing feedback in preparation for corporate audits, agency ... or regulatory affairs + Experience in Quality Assurance or GxP function + Strong compliance knowledge +...to meet multiple overlapping timelines. + Proficient in global IT tools such as Track Wise, Regulus, SharePoint. +… more
- AbbVie (Branchburg, NJ)
- …communicating with stakeholders and delivering to meet business needs. + Ensures IT compliance and adherence to applicable internal and external regulations ... and resolves client and BTS relationship issues. Manages and provides expert advice on, the selection, design, justification, implementation and business use… more
- Verista (Boston, MA)
- …Operations areas. This position will be working closely with the operational functions, DTE ( IT ), and other GxP QA groups to provide oversight of computerized ... the implementation and use of computerized systems in all GxP areas * Participates in system implementation project teams...integrity * Identifies and escalates areas of risk or non- compliance to manager / leadership team * Participates in… more
- BeiGene (San Mateo, CA)
- …A key focus will be on strategic alignment, collaborating cross-functionally and cross- GxP to ensure that R&D Quality Management Systems (QMS) are optimized for ... both compliance and innovation. This role is pivotal in fostering...requirements. + Build and maintain strong cross-functional partnerships across GxP areas (GCP, GMP, GVP) to ensure alignment in… more
