- ThermoFisher Scientific (Wilmington, NC)
- …Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** **Job Summary** As the GCP Compliance and Process Lead at Thermo Fisher Scientific, ... field + Solid knowledge of drug development, clinical trial management, and/or GCP compliance processes + Proven awareness of sponsor oversight requirements… more
- ThermoFisher Scientific (Greenville, NC)
- …Conditions** Office **Job Description** Join Thermo Fisher Scientific Inc. as an outstanding GCP Compliance Oversight Manager and play a crucial role in ensuring ... field + Solid knowledge of drug development, clinical trial management, and/or GCP compliance processes + Proven track record of strong project management skills… more
- Capgemini (Alpharetta, GA)
- …Lead the refactoring and transformation of Lambda-based workloads to align with GCP -native patterns. + Compliance & Security: Ensure solutions are compliant ... and Payments domain, with attention to security, latency, and compliance requirements. + GCP Associate Cloud Engineer certification is highly preferred. + Prior… more
- Capgemini (Atlanta, GA)
- …drive the migration of critical payment processing workloads from AWS Lambda to GCP Cloud Functions, ensuring compliance , scalability, and performance in a ... GCP Architect Choosing Capgemini means choosing a company...+ Stakeholder Collaboration: Work closely with payment systems architects, compliance officers, and business teams to align cloud architecture… more
- Bristol Myers Squibb (Princeton, NJ)
- …pipeline. This position, Manager, will support various TS laboratory heads and scientists to ensure GCP compliance is met based on the intended use of each lab. ... of 5 years of clinical lab operations, quality and/or compliance ; experience in pharma, biotech, CRO, or medical device...Regulation (QMSR). Knowledge of global quality standards and regulations ( GCP , GLP, GDP, and ICH GCP ), and… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management and Statistics, with at least 3 years of experience in GCP Quality/ Compliance . + Advanced knowledge of pharmaceutical development, medical affairs ... the role:** The Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring the quality of processes...and GCP /GVP regulations including FDA, EU, MHRA, PMDA and ICH.… more
- Kelly Services (Bothell, WA)
- …clinical quality procedural documents, including SOPs and work instructions, to ensure compliance with GCP , GLP, and GVP regulations. * Provide training, ... guidance, and mentorship to staff and internal teams on GCP , GLP, GVP compliance , audit processes, and regulatory inspection readiness. * Oversee the management… more
- Clarkston Consulting (Philadelphia, PA)
- …Practices ( GCP ) + Plan, identify, coordinate, and execute implementation of GCP Compliance solutions in support of clinical programs + Establish/implement ... laboratories and investigator sponsored trials + Perform training and education of global GCP standards + Review clinical and data operational plans and protocols +… 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
- Takeda Pharmaceuticals (Boston, MA)
- …Management and Statistics, with at least 3 years of experience in GCP Quality/ Compliance . + Advanced knowledge of pharmaceutical development, medical affairs ... Clinical Program Quality Investigations is responsible for ensuring the compliance of deviation management and serious breach process. This...and GCP /GVP regulations including FDA, EU, MHRA, PMDA and ICH.… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- …and compliance with applicable regulations and guidelines that ensure sustained GCP /QSR compliance . + **Vendor Management:** Leads and develops systems for ... procedures to ensure that the business units quality management and compliance program are effective and efficient in identifying, detecting, and correcting… more
- Leidos (Aurora, CO)
- …Design and manage secure cloud architectures in AWS, Azure, and/or Google Cloud ( GCP ), ensuring compliance with security standards. + Integrate security into ... cross-functional teams to develop, deploy, and maintain cybersecurity frameworks, ensuring compliance with industry standards and regulatory requirements. + Play a… 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
- Terumo Neuro (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
- Caris Life Sciences (Phoenix, AZ)
- …group. + Responsible for ensuring sample integrity and maintaining Good Clinical Practice ( GCP ) compliance for samples through chain of custody, sample handling ... Subject Protection, HIPAA, and IATA training. + All job specific, safety, and compliance training are assigned based on the job functions associated with this… 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
- 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
- Regeneron Pharmaceuticals (Armonk, NY)
- …from a quality perspective in conjunction with the business and the GDQM ( GCP ) team. * Providing day-to-day quality and compliance support to cross-functional ... The Senior Manager, Global Development Quality Management ( GCP ) acting as a Quality Management Lead (QML)...guidance and leadership for all aspects of quality and compliance within Global Development Quality (GDQ) systems. The GDQM… more
- Takeda Pharmaceuticals (Boston, MA)
- …departmental objectives, representing GCP Excellence globally. Develop and implement GCP Excellence processes to enhance support and compliance , identifying ... you to shine? Join us as a Senior Manager, GCP Excellence in Clinical Trials based remotely reporting to...strategy with Clinical Quality Assurance (CQA) and Global Development Compliance partners is actioned to study execution teams. +… more
- Insight Global (Chadds Ford, PA)
- …digital technologies and data analytics - Experience with clinical trial vendor companies and GCP compliance - Masters Degree or MBA - PMP certification or ... similar null We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters.… more
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