- BeiGene (Emeryville, CA)
- …For more information, please visit www.beigene.com. **General Description:** The Director, GCP Compliance , Americas provides quality guidance, expertise and ... leadership to the regional Clinical Operations Americas GCP compliance team. The Director GCP Compliance collaborates effectively with stakeholders… more
- Takeda Pharmaceuticals (Columbus, OH)
- …company to inspire you and empower you to shine? Join us as an Associate Director, GCP Compliance based remotely reporting to the Director, GCP Compliance ... + Lead clinical trial functional areas and study teams on issues related to GCP compliance and liaise with study execution teams on compliance to clinical… more
- AbbVie (North Chicago, IL)
- …Clinical Process Compliance is accountable for the interpretation and application of GCP compliance and quality principles as they relate to clinical trial ... clinical trial conduct. Acts as Primary Point of Contact for all GCP compliance -related questions and issues, leading the clinical trial issue escalation process… more
- Takeda Pharmaceuticals (Boston, MA)
- …on quality compliance activities. + Provide guidance and support to GCP , PV Health Authority inspections including logistics. + Present insights to the health ... and Statistics, with at least 3 years of experience in GCP Quality/ Compliance . + Advanced knowledge of pharmaceutical development, medical affairs and … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …priorities, by reviewing and monitoring the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from the internal ... by reviewing and monitoring the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from the internal and external… more
- ICON Clinical Research (Winston Salem, NC)
- …personnel to improve and implement globally working practices and systems, in compliance with GCP and appropriate regulations to ensure best practices ... ) legislation, guidelines and international standards. + Provide training on GCP , and other compliance and quality related topics, as required to improve quality… more
- J&J Family of Companies (Santa Clara, CA)
- …all belong. Position Overview The Sr. Clinical Quality Assurance Auditor will provide GCP and compliance -related audits of internal and external Clinical Studies ... in process, support updates of procedures in compliance with applicable regulations and perform vendor audits as needed. This work is accomplished with moderate… more
- Actalent (Chicago, IL)
- …and schedules. + Plan, conduct, and close out clinical studies in compliance with quality standards (ICH/ GCP , Global Regulations). + Lead cross-functional ... tools, clinical research, and patient recruitment. + Knowledge of GCP , regulatory compliance , and CRC processes. + Skills in pre-screening patients, chart… more
- Information Technology Strategies (Camp Springs, MD)
- …lifecycle. + Will architect and maintain secure cloud infrastructure on AWS, Azure, or GCP , ensuring compliance with frameworks such as FedRAMP or NIST. + Will ... Code (IaC) frameworks like Terraform or Ansible to enforce compliance and security best practices. + Will collaborate with...+ Proficiency in cloud platforms like AWS, Azure, or GCP , with expertise in cloud-native security tools. + Previous… more
- Insight Global (Chantilly, VA)
- …seamless integration between OpenShift and cloud platforms like AWS, Azure, or GCP Security & Compliance : Implement security best practices for containers ... and Kubernetes, ensure compliance with industry standards, and conduct regular security audits...Groovy Cloud Platforms: Familiarity with cloud platforms like AWS, GCP , or Azure and their integration with OpenShift Monitoring… more
- Applied Research Associates, Inc. (Herndon, VA)
- …ensuring seamless integration between OpenShift and cloud platforms like AWS, Azure, or GCP + **Security** **& Compliance ** : Implement security best practices ... for containers and Kubernetes, ensure compliance with industry standards, and conduct regular security audits...+ **Cloud Platforms:** Familiarity with cloud platforms like AWS, GCP , or Azure and their integration with OpenShift +… more
- MicroVention, Inc. (Aliso Viejo, CA)
- …and FDA regulations. Job duties: + Develop and implement SOPs to ensure GCP /ICH compliance for data management, database operations, clinical report writing, ... Audit data management vendors, as appropriate. + Assure regulatory compliance of vendors with company SOPs, FDA and ICH...skills, ability to coach and mentor. 4. Knowledgeable in GCP standards, FDA and ICH guidelines, and recommended CDM… more
- CSL Behring (King Of Prussia, PA)
- …Quality Assurance. You will partner with customers to assess and support compliance with international guidelines (eg ICH- GCP ), applicable international and ... and other Clinical regulatory expertise to support us in maintaining required compliance : + Provide GCP and process related support. + Perform GCP review of… more
- Houston Methodist (Houston, TX)
- …sponsor, and institution to support and provide guidance on the administration of the GCP compliance , financial and other related aspects of the research study. ... Institutional Review Board (IRB) and regulatory documents for submission assuring compliance with local and federal regulatory standards as appropriate and required… more
- CVS Health (Cumberland, RI)
- …leading all GCP IAM efforts to align with CVS regulatory compliance , contractual obligations and make recommendations for improvement. + Driver towards adoption ... care more personal, convenient and affordable. **Position Summary** The Security Engineer - GCP Identity & Access Management (IAM) is a critical member of the… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …the conduct of clinical studies. **Job Duties** + Maintain, and monitor Olympus GCP processes and procedures for compliance with applicable regulations and ... + Perform reviews of clinical study documentation for data integrity and compliance with GCP guidelines and regulation, including Quality Control checks… more
- Prime Therapeutics (Columbus, OH)
- …and drives every decision we make. **Job Posting Title** Sr. IT Software Engineer - GCP (Sr. Data Engineer) - Remote **Job Description** The Sr. Software Engineer - ... GCP (Sr. Data Engineer - GCP ) is...**Preferred Qualifications** + Experience working in environment with regulatory compliance requirements (HIPAA, PCI, etc.) + Previous experience working… more
- Chiesi (Cary, NC)
- Senior GCP Auditor Date: Dec 12, 2024 Department: Corporate R&D Quality Assurance Job Type: Direct Employee Team: Quality Contract Type: Permanent Location: Cary, ... **_Who we are looking for_** **Purpose** To assure the compliance and the correct application of Good Clinical Practice... and the correct application of Good Clinical Practice ( GCP ), inside the clinical development of the Global R&D… more
- HSBC (Buffalo, NY)
- …our people, our investors, our communities and the planet we all share. Our GCP Cloud DevOps Engineer will work within an agile team of Engineers and Operations ... personnel building highly resilient, scalable and performant GCP infrastructure in an automated and efficient manner. In this role you will work alongside the… more
- University of Miami (Miami, FL)
- …upon timelines Audit Data Management Contract Research Organizations for FDA CFR and ICH GCP Compliance This list of duties and responsibilities is not intended ... to be all-inclusive and may be expanded to include other duties or responsibilities as necessary. CORE QUALIFICATIONSEducation: Bachelor's degree in relevant fieldExperience: Minimum 1 year of relevant experience Knowledge, Skills, and Attitudes:* Excellent… more
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