- 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
- IQVIA (Durham, NC)
- …experience in pharmaceutical, technical, or related area, of which 3 years in Quality + Assurance Audits. GCP experience. Equivalent combination of education, ... **Overview:** **Plan and conduct independent clinical ( GCP ) audits to assess compliance with regulations, guidelines,...Effectiveness Check (EC) plans and track till closure for quality events arising from Audits; and from Quality… more
- Regeneron Pharmaceuticals (Tarrytown, 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
- United Therapeutics (Silver Spring, MD)
- …10+ years of direct biotech/pharmaceutical industry experience + 5+ years of experience within GCP Quality + GCP experience + Experience performing CQA ... years in a clinical process or operations role + Certified Quality Manager (CQM)-ASQ RQAP- GCP and/or ASQ-CQA + Experience providing support with trials crossing… more
- BeiGene (San Mateo, 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
- J&J Family of Companies (Irvine, CA)
- …and other quality functions to develop and implement an effective GCP quality program. + Lead and/or participate in cross-functional, cross-segment and/or ... Johnson & Johnson is seeking a Manager, Clinical Quality Lead to provide Clinical quality ...compliance-related activities within the business unit in Good Clinical Practice( GCP , ISO 14155:2020), as well as other applicable external… more
- Lilly (Indianapolis, IN)
- …- MQO is to support the development and implementation of the strategy for the GCP quality systems and activities to support business goals and objectives. This ... includes execution of GCP quality ...includes execution of GCP quality system deliverables to ensure compliance, quality ...or equivalent work experience + Demonstrated ability to apply GCP quality systems within a regulated work… more
- AbbVie (Irvine, CA)
- …- 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
- Vera Therapeutics (Brisbane, CA)
- … Assurance and will be responsible for developing and maintaining GMP, GLP and GCP Quality Management Systems in accordance with FDA, ICH, EMA regulations and ... Title: Associate Director, Quality Assurance Location: Brisbane, CA About Us: Vera...employees and vendors. * Provide QA for GMP, GLP, GCP environment(s) and Document Control. * Manage the investigation… more
- Abbott (South Portland, ME)
- …deficiencies. + Maintain current knowledge of therapeutic areas, SOP's, IVDR and ICH- GCP guidelines. + Oversee management of clinical quality documentation, ... science or related field. + 8+ years' experience in Good Clinical Practice ( GCP ) and/or Quality Assurance Environment, including 5+ years clinical study/project… more
- Pfizer (Collegeville, PA)
- … Quality Review Team (QRT) + Audits and Inspection Coordination: Drive GCP quality in withstanding regulatory scrutiny, operational data and documentation. ... pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality , GxPQuality, and/or regulatory + Regulatory inspection… 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
- 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
- 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
- Mayo Clinic (Rochester, MN)
- …to succeed. **Responsibilities** **We are seeking a Senior Software Engineer focused on GCP Stack data pipelines and data management. In this role, you will work ... a member of a highly skilled team with deep GCP experience in Big Query, Dataflow, Data Fusion, Data...processes, and optimization efforts focused on data delivery, scalability, quality , and efficiency. You will also participate in the… more
- L'Oreal USA (New York, NY)
- …like Row and Column Level Security + Experience implementing Data Governance and Data Quality standards + Experience in GCP and PowerBI performance tuning and ... and every person around the world the best of beauty in terms of quality , efficacy, safety, sincerity and responsibility to satisfy all beauty needs and desires in… more
- System One (Durham, NC)
- Job Title: QA Consultant ( GCP Compliance) Location: Remote with potential travel to company sites as needed. Hours/Schedule: 20hrs/wk for first few months, then ... audit with a strong focus on Good Clinical Practice ( GCP ) compliance. The ideal candidate will have a deep...get work done more efficiently and economically, without compromising quality . System One not only serves as a valued… more
- Loyola University Chicago (Chicago, IL)
- …research sample supplies + Participates in Cooperative Group Audits, FDA , Sponsor GCP quality audits, Loyola internal audits and department audits. + Performs ... protocol are adhered to in accordance with FDA , GCP , and ICH Guidelines. + Serve as primary...protocol are adhered to in accordance with FDA , GCP , and ICH Guidelines. + Serve as primary… more
- HCA Healthcare (Brentwood, TN)
- …systems and business processes to maintain compliance with privacy practices (eg HIPAA), quality standards (eg GCP ), and regulations for electronic records (eg ... that we continue to provide all patients with high quality , efficient care. Did you get into our industry...quality standards, and software validation guidelines (eg HIPAA, GCP , 21 CFR Part 11, FDA CSV Guidance, Annex… more
- Insight Global (Dearborn, MI)
- Job Description Insight Global is looking for a GCP Data Engineer to join a large automotive client. In this role you will be working with the clients customers to ... and analysts to understand data requirements Ensure data integrity and quality across all data platforms Optimize data processing workflows for performance… more
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