- Takeda Pharmaceuticals (Columbus, OH)
- … quality and compliance in clinical development in partnership with R&D Quality and GCP Functions. We champion continuous improvement, foster innovation, and ... and accelerate the delivery of medicines to patients. **Job Description:** As a GCP Process Excellence Intern, you will have the opportunity to contribute to… more
- BeiGene (San Mateo, CA)
- …for implementing and maintaining a balanced, proactive, and phase appropriate approach to GCP Quality Assurance. This position will be primarily responsible for ... authority inspections. **Essential Functions of the job:** Manage and oversee the GCP Quality Assurance activities: + Conduct and/or oversee the quality … more
- Takeda Pharmaceuticals (Columbus, OH)
- …to address risks and issues + Develop, lead and oversee compliance assessments to address GCP Quality Plan, CAPAs/ECs and liaise with QA to ensure adherence to ... you to shine? Join us as an Associate Director, GCP Compliance based remotely reporting to the Director, ...and drive the implementation of compliance management related to quality events and internal audits for clinical trial delivery… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The Manager, Global Development Quality Standards & Continuous Improvement (GDQSCI) will support the GDQSCI team with activities related to the maintenance of the ... Global Development Quality Management System (QMS), quality event oversight...you if have:** * Knowledge, understanding and application of GCP , and/or GVP guidelines including the management of fundamental… more
- BeiGene (Emeryville, CA)
- …For more information, please visit www.beigene.com. **General Description:** The Director, GCP Compliance, Americas provides quality guidance, expertise and ... in the biotech/ pharmaceutical sector, with minimum of 6-8 years in GCP -related discipline/ quality assurance role + Solid leadership and demonstrated experience… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and Specialty Medicine strategic priorities, by reviewing and monitoring the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the ... Quality Leads (RQLs) by reviewing and monitoring the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from the… more
- AbbVie (North Chicago, IL)
- …- Clinical Quality Assurance is primarily responsible for leading the management of GCP quality activities in support of studies and projects across one or ... policies and functional procedures and applicable global regulations. As the primary GCP quality interface cross-functionally in R&D for the product, this… more
- Amgen (Washington, DC)
- …Diagnostics and Supplier Quality (PMDSQ) and will be responsible for the Quality oversight of GCP , GLP and GPvP regulated suppliers and service providers ... lives of patients while transforming your career. **R&D Supplier Quality Senior Manager** **What you will do** Let's do...quality management or oversight + Working knowledge of GCP , GLP and GPvP regulations, practices, and trends +… more
- ICON Clinical Research (Winston Salem, NC)
- …for efficient and effective delivery of service. + Comply with company quality framework, regulatory ( GCP ) legislation, guidelines and international standards. + ... Provide training on GCP , and other compliance and quality related topics, as required to improve quality and expertise within the operation of the regional… more
- Actalent (Morrisville, NC)
- …internal, and regulatory authority audits. + In-depth industry knowledge of quality compliance and GCP regulations. + Excellent interpersonal, leadership, ... psychometric ratings for clinical trials in accordance with FDA, GCP , and protocol guidelines. + Assume a lead role...to subjects. + Ensure adherence to COP's, SOP's, and GCP (ICH GCP and local regulations). Essential… 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 ... of my knowledge. **Job Description** **OBJECTIVES:** + Ensures Global and R&D Quality processes are embedded and effectively implemented across CPMQ + Partner with… more
- Pfizer (New York, NY)
- …years of pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality , GxP Quality , and/or regulatory + Regulatory ... **ROLE SUMMARY:** The Issue Lead will be responsible for driving Quality Event (QE) case management, ensuring that investigations are conducted thoroughly within… more
- Bio-Techne (Austin, TX)
- …in compliance with all applicable regulations, standards, systems, procedures and practices including Quality System, cGMP, GLP, GCP , CLIA, ISO, FDA, ICH, EU and ... to further treat and prevent disease worldwide.** The Senior Quality Assurance Specialist will work closely with internal colleagues...independently with minimal supervision + Knowledge of cGMP, GLP, GCP , CLIA, ISO, OSHA, CE, IVD required **Who We… 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...GCP (Sr. Data Engineer - GCP ) is responsible for leading the design of technology...new ideas and work collaboratively to provide the highest quality of care and service to our members. If… 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: ... (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and...compliance and the correct application of Good Clinical Practice ( GCP ), inside the clinical development of the Global R&D… more
- Publicis Groupe (New York, NY)
- …in a range of technologies and processes including: + Proficiency in GCP - essential + Strong knowledge of security architecture principles, frameworks, and ... conduct research using vendor documentation + Capability to create and maintain high- quality documentation + Possession of an adversary mindset + Continuous learning… more
- ThermoFisher Scientific (Carlsbad, CA)
- …Clinical Research Site audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines, and client contractual ... obligations. Identify issues impacting the quality and/or integrity of clinical research programs, determine root...to address issues. Perform technical document review and other GCP practice activities in support of clinical development programs.… more
- IQVIA (Durham, NC)
- …in Life Science or related field. + At least 5 years experience in GCP Quality Assurance within pharmaceutical, technical, or related areas. + Considerable ... knowledge of GCP , clinical trial, regulations and quality assurance auditing techniques. + Fluent English language capabilities. **Skills** + Ability to work… more
- Niagara Bottling LLC (Diamond Bar, CA)
- …want to be part of achieving our mission to provide our customers the highest quality most affordable bottled water. Consider applying here, if you want to: + Work ... Sr. Software Engineering Manager - (MERN Full Stack and AWS/ GCP /Azure) The Senior Manager of Full Stack team will...are completed on time, within budget, and meet all quality standards. + Innovation & Continuous Improvement: Drive continuous… more
- Capgemini (New York, NY)
- GCP Devops Engineer Choosing Capgemini means choosing a company where you will be empowered to shape your career in the way you'd like, where you'll be supported and ... and build a more sustainable, more inclusive world. **Role** **Role : GCP Devops Engineer** **Location: NYC** **Responsibilities** 1. Build deploy and maintain CI/CD… more
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