- 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 (Austin, TX)
- …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
- Takeda Pharmaceuticals (Juneau, AK)
- …readiness and process adherence into ways of working. + Partner with R&D Quality and GCP Compliance Management to develop GCP inspection strategy in support ... Collaborate across GCP Excellence in Clinical Trials and with GCP Compliance Management to prepare and facilitate internal audits and regulatory inspections… more
- Capgemini (New York, NY)
- …identity and access management (IAM) policies, ensuring least privilege access across GCP services. + Compliance Assurance: Assist in ensuring compliance ... GCP Security Engineer (SecDevOps) Choosing Capgemini means choosing...**Salary Transparency Language** Capgemini discloses salary range information in compliance with state and local pay transparency obligations. The… more
- Lundbeck (Deerfield, IL)
- …audits, in accordance with approved annual audit schedule. + Provide unsupervised PV & GCP expertise and compliance advice to stakeholders in R&D, supporting the ... PV and GCP QA Quality Advisor - Remote Opportunity Requisition...and support the R&D Quality Assurance Division in assuring compliance of established processes and procedures with relevant regulatory… more
- Takeda Pharmaceuticals (Providence, RI)
- …both sponsor and investigator sites. **ACCOUNTABILITIES:** + Provide expertise in GCP compliance interpretation, consultation, training, and recommendations to ... lead clinical development teams in preparation for announced inspections and provide GCP compliance technical support during inspections of investigator sites… more
- Vera Therapeutics (Brisbane, CA)
- …Director is responsible for implementing strategies and tactics to promote and maintain GCP compliance , and to lead overall Inspection Readiness for Vera. ... to clinical study teams. * Ensures the implementation and maintenance of GCP compliance procedures and operations to ensure a robust quality management system… more
- ThermoFisher Scientific (Waltham, MA)
- …clinical and commercial services space, with a focus on FDA regulations, cGMP, and GCP compliance . Partner with Thermo Fisher's Chief Compliance Officer and ... **Environmental Conditions** Office **Job Description** Lead Counsel, Head of Regulatory Compliance At Thermo Fisher Scientific, we are dedicated to creating… 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
- United Therapeutics (Silver Spring, MD)
- …support with trials crossing into International regulation requirements for the purposes of GCP compliance and EMA expectations + Good Laboratory Practice (GLP) ... of the organization's active clinical trials, and to maintain compliance to federal and international GCP regulations,...to maintain compliance to federal and international GCP regulations, as well as internal policies and procedures.… more
- Rhythm Pharmaceuticals (Boston, MA)
- …will oversee GCP activities across various areas of development, ensuring compliance , and quality execution of clinical trials. The individual will lead and/or ... audits + Draft, review, revise, or provide input to GCP /GLP SOPs to assess consistency and compliance ...to GCP /GLP SOPs to assess consistency and compliance with regulatory requirements and internal standards + Interact… more
- GE HealthCare (MA)
- …quality control/ analysis techniques. **Job Description** + Ensure image quality review and GCP compliance of clinical studies and business requests during image ... solutions when possible. + Perform project specific tasks in compliance with Good Clinical Practices ( GCP ), regulatory...tasks in compliance with Good Clinical Practices ( GCP ), regulatory requirements (21CFR Part 11, GDPR, HIPAA, etc.),… more
- Novo Nordisk (Plainsboro, NJ)
- …in compliance with all existing applicable requirements and overall ensuring ICH GCP compliance for the clinical trial(s) + The tasks will be performed ... internal affiliates, CROs, third party vendors, and contractor to ensure compliance with study protocol. Resolves or escalates major/cross-program issues, supported… more
- Kelly Services (Sunnyvale, CA)
- …Identify and suggest ways to resolve problems or issues at site associated with GCP or protocol compliance which could affect the integrity of the data ... specific ICF Maintain a high level of familiarity with GCP and assigned protocols. **The essential requirements of the...current on clinical trial regulatory requirements and guidelines (eg GCP , ICH, FDA, etc) with the ability to translate… more
- Ascendis Pharma (Palo Alto, CA)
- …and supporting implementation of CAPAs as necessary + Work Closely with Ascendis GCP /PV Compliance team and Commercial organization as required to ensure ... but is not limited to: + Through coordination with Ascendis GCP and PV Compliance team will provide appropriate representation during PV related regulatory… 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
- 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
- Actalent (Tampa, FL)
- …related approved responsibilities as required. Essential Skills + Oncology research coordination + GCP compliance + CRF and ICF management + Patient consenting + ... + Periodically audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and… 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