- 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
- J&J Family of Companies (Raritan, NJ)
- …and Medical Device Cybersecurity + Implementing Monitoring & Controls to ensure compliance with GxP regulations + Maintaining qualified personnel and building ... of business experience, with a strong emphasis on Quality, Compliance and IT is required + Bachelor's...including experience with external auditing bodies + Understanding of IT Security requirements preferred + Expert knowledge… more
- CREO (Durham, NC)
- …with regulatory compliance standards, such as SOC2, NIST, HIPAA, GDPR, GxP , etc. + Experience with formal change management practices and procedures. The ... JOB DESCRIPTION OVERVIEW The Senior IT Engineering Consultant will be responsible for assessing,...cost estimates for new opportunities. + Provide timely and expert ad-hoc advisory services to address client needs. +… more
- Bristol Myers Squibb (Princeton, NJ)
- …validation and testing strategies. + Ensures adherence to software development practices, compliance , and key IT controls + Coordinate with cross-functional ... CSV projects ensuring efficiency, consistency, quality of work and compliance with external regulations and internal procedures. Collaborate with...standards. + Ability to coach teams across functions on GxP processes, IT controls as well as… more
- Merck (Lower Gwynedd, PA)
- …for the execution of method optimization, troubleshooting, and clinical sample analysis within a GxP laboratory + Act as subject matter expert with internal or ... bioanalytical group located at our company's new state-of-the-art AdVAnce GxP research facility in West Point, PA. At this...facility, we will combine the power of innovative robotics, IT platforms, and science to accelerate vaccines and enable… more
- BeiGene (San Mateo, CA)
- …needs and the Quality Strategy. + Act as the system owner for all digital GxP enterprise Quality applications. + Maintain the Digital QMS in compliance with ... implementations and enhancement projects in collaboration with Business Process Owners and IT . + Define and maintain a digital quality systems onboarding and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …strategy as the global process owner. The incumbent functions as a subject matter expert for quality and compliance issues. This role provides support to the ... associations as appropriate + Perceived as thought leader possessing subject matter expert knowledge of assessing compliance to global regulations + Manages… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …of the most challenging global health issues. The Director, Quality and Regulatory Compliance , Compliance Programs is responsible for helping to shape, implement ... and support the maintenance of the BD Q&RC compliance programs. This role contributes to the definition of...This role requires demonstrated experience with the US FDA GXP regulations and have a working knowledge on quality… more
- Sanofi Group (Bridgewater, NJ)
- …+ Compliance of Computerized systems (REMS, GDPR, PHI, PII, GxP ) + Patient Service/Healthcare experience desired **TRANSVERSAL SKILLS & COMPETENCIES (SOFT ... cloud technologies, batch data processing, real-time API integration, and regulatory compliance for pharmaceutical or healthcare systems. The role ensures that our… more
- Kelly Services (Rochester, MN)
- … inspection readiness. + Conduct audits on raw data and final reports for compliance with GxP , study protocols, and laboratory procedures. + Monitor and ensure ... + Review documentation for adherence to quality standards. + Ensure compliance of facilities, equipment, processes, and procedures with regulations and company… more
- Cognizant (Raritan, NJ)
- …and other automation tools to streamline processes and reduce errors. 5. **Regulatory Compliance & ITIL** . Operate under GxP guidelines, ensuring strict ... Linux (Ubuntu) at an L2 level, Tableau reporting, and IT support in manufacturing or lab environments is a...using SCCM, Intune, Autopilot, and Entra, ensuring security and compliance . . Maintain and optimize Group Policy Objects (GPOs),… more
- Sanofi Group (Cambridge, MA)
- …Global External Manufacturing function. This position provides quality leadership and compliance oversight for multiple products manufactured by CMOs and Alliance ... manufacturing network while driving continuous improvement and ensuring regulatory compliance . **Main Responsibilities:** + Serve as the primary Quality contact… more
- Charles River Laboratories (Mattawan, MI)
- …of people across the globe. Whether your background is in life sciences, finance, IT , sales or another area, your skills will play an important role in the ... time of bioanalytical data. Staff are also knowledgeable in the application of GxP 's and applicable SOPs, along with adhering to study protocols to accurately… more
- Charles River Laboratories (Mattawan, MI)
- …of people across the globe. Whether your background is in life sciences, finance, IT , sales or another area, your skills will play an important role in the ... time of bioanalytical data. Staff are also knowledgeable in the application of GxP 's and applicable SOPs, along with adhering to study protocols to accurately… more
- Lilly (Indianapolis, IN)
- …of the Advisor MQO Corporate role is to be the quality expert for their given area of responsibility (regional/affiliate, portfolio and/or functional business ... execution of regulations on a local, regional, and global level ensuring compliance and inspection readiness. + Accountable for the development and implementation of… more
- Novo Nordisk (Plainsboro, NJ)
- …FICO, OTC (Order to Cash), Logistics, MM and PO technical competencies + Ensures compliance with the Sarbox, GxP and applicable regulatory requirements to fulfil ... all levels of management and staff throughout Novo Nordisk IT to implement and support business solutions. Essential Functions:...OpenText, Model N, MDL, UPS, Salesforce, Ventis, Vertex) + Expert application of CFR Title 21 Part 11 requirements,… more
- AbbVie (North Chicago, IL)
- …regarding applicable Corporate and Divisional Policies, including code of conduct, safety, GxP compliance , and data security. Qualifications + Bachelor's Degree ... YouTube and LinkedIn. Job Description As a recognized multidisciplinary expert , drives functional performance by designing and implementing solutions aimed… more
- Kelly Services (Columbus, OH)
- …is an individual contributor role primarily responsible for conducting technical quality compliance related activities in accordance with GxP regulations and ... identified and implemented based on associated risk to process, compliance or SISPQ. Additionally, the individual is responsible for...hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical… more
- Kelly Services (Pennsauken, NJ)
- …maintain quality assurance across all stages of production and ensure compliance with company policies, regulatory requirements, and safety standards. **Essential ... quality reviews of documentation and production processes to ensure compliance with cGMP standards. + Collaborate with teams to...manufacturing environment or a similar role + Familiarity with GxP , FDA, ICH, and OSHA requirements + Proficient in… more
- AbbVie (Cincinnati, OH)
- …communicating with stakeholders and delivering to meet business needs. + Ensures IT compliance and adherence to applicable internal and external regulations ... business and resolves client and BTS relationship issues. Manages and provides expert advice on the selection, design, justification, implementation and business use… more