- Merck & Co. (Rahway, NJ)
- …Standard Operating Procedures (SOPs) and ICH- GCP guidelines. Works with management to maintain the consistent execution of quality global procedures. ... Job DescriptionUnder the direction of the applicable management , the Lead Clinical Data Manager...partners to achieve common objectives. Is accountable for the quality and timely execution and delivery of deliverables at… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Production data transfers for diverse data sets and identifies any erroneous data. Lead Companion Diagnostics data management activities by acting as a ... Provide oversight and execution of the CDx development for Daiichi Sankyo Programs. Lead the Data Management aspects of diagnostics across Daiichi's early… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …builds and maintains positive relationships with internal/external stakeholders/vendors/partners. - Project Management : Is accountable for quality of delivery in ... oversee quality of external data, transfer standards, and issue management . Ensure consistency of standard implementation across programs. Is accountable for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of R&D QA. Within assigned GPTs, facilitate the implementation of a risk-based quality management process fully embedded through trial design, execution and ... research areas centered around rare diseases and immune disorders.Summary Lead the implementation of the quality strategy...other GxP QA functions (GMP/ IMP QA, Audit Compliance, Quality Management System [QMS] QA, PV/MA … more
- Eisai, Inc (NJ)
- … management ; providing guidance to study teams on vendor selection and management options in alignment with global strategies. Lead the process of Request ... from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities related to the outsourcing of clinical services to… more
- Eisai, Inc (Nutley, NJ)
- …timelines.Responsibilities include, but are not limited to, serving as the statistical lead on project teams. This involves providing valuable statistical input on ... as needed.Overall, the incumbent is entrusted with the leadership and effective management of statistical activities, contributing significantly to the success of a… more
- Merck & Co. (Rahway, NJ)
- …performance and compliance for assigned protocols in a country in compliance with ICH/ GCP and country regulations, our company's policies and procedures, quality ... results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.Contributes to the development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategic operational considerations Clinical representative of executive teams including, the Quality Counsel, Executive Safety Committee, GxP Risk Management ... US. Within the Global Development organization this is a key new role to lead the Clinical Operations function across our Boston, MA and Princeton, NJ campuses… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operations clinical trial activities, ensuring adherence to timelines, budgets, project, and quality plans, and relevant ICH/ GCP Guidelines Review protocols to ... activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data, and quality .Establish...and tools to achieve excellence in trial operations and management .Monitor and ensure compliance and highest quality … more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …audienceAt least 8 years' experience in the biotech/pharmaceutical industry in validation, quality management , process controls, and continuous improvement in an ... Position Summary:Oversee and lead the validation program for production equipment and...commercialization. Serve as a technical resource to improve product quality , reliability, and process capability. Support manufacturing to satisfy… more
- LL Bean (Yarmouth, ME)
- …partnerships with key vendors.Strong organizational skills, ability to guide and lead through change.Direct people management responsibilities.If you care about ... stakeholders.Essential Functions:Own the application suite end-to-end architecture vision and roadmap. Lead a team of architects and engineers in designing and… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …Global Development Quality Management ( GCP ) acting as a Quality Management Lead (QML) is a key position that will provide mentorship and ... with study teams, relevant functions and other GDQ functions. Lead risk-based quality activities on all Regeneron-sponsored...areas. + Responsible for the management of GCP -compliant activities from a quality perspective in… more
- GE HealthCare (Boston, MA)
- …may develop and monitor key quality metrics to assess the effectiveness of quality management systems and report findings to senior management and ... functional QA subject matter expert + Participates in the quality management system (QMS) improvements. + Overall,...system (QMS) improvements. + Overall, the role of a GCP Quality Assurance Auditor is multifaceted, requiring… more
- CVS Health (Hartford, CT)
- …use of data, analytics, and advanced AI. We are looking for passionate and motivated Lead Data Engineers to join our growing team of engineers. We are on a mission ... for insights and reporting. + Creating and maintaining data models ensuring data quality , and efficiency. Design solutions that can scale with growing data volumes… more
- Lilly (Indianapolis, IN)
- …quality projects, ensuring alignment with GxP regulations and adherence to Lilly's Quality Management System (QMS). Responsibilities: Quality Systems and ... regulatory requirements, ensuring a comprehensive understanding of their impact on the Quality Management System (QMS), thereby facilitating the submission of… more
- Philips (Orange, OH)
- …+ You've acquired a minimum of 7+ years' experience working in FDA regulated Quality Management Systems (QMS)/Clinical environments, with a minimum of 3 years ... The Senior Good Clinical Practice ( GCP ) Auditor will play a critical role in...Studies and practices are compliant with Internal/External regulatory and quality standards. **Your role:** + Executing & leading Good… more
- Ford Motor Company (Columbus, OH)
- …dynamic team. The ideal candidate will have a strong background in database management , Informatica, batch and ETL job processing, and a good understanding of cloud ... platforms, specifically Google Cloud Platform ( GCP ). This role involves designing, developing, and maintaining scalable...and maintain efficient, reusable, and reliable code for database management , batch jobs, and ETL processes. + Work with… more
- AbbVie (North Chicago, IL)
- …to support the clinical trial conduct and their overall compliance with ICH GCP guidelines, applicable regulations, and the organization's Quality System. + ... in compliance with worldwide regulatory expectations and requirements. + Lead and develop strategy for global Quality ...regulations, guidelines, policies and procedures. + Plan, organize and lead multiple GCP vendor compliance audits on… more
- Novo Nordisk (Lexington, MA)
- …such as inspection host & back-room lead + Experience with clinical quality assurance, clinical trial management /monitoring or GCP Audits + ... for patients. Do you dream of using your solid GCP knowledge, process optimisation skills and quality ... Quality - will also act as the Clinical Quality Line of Business/ key project(s) lead … more
- Merck (Columbus, OH)
- … quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities. The CQOM will ... and follow up of regulatory inspections. **Primary Responsibilities:** Operational Quality Management + Develop Risk Assessment and...levels of knowledge and skill in order to effectively lead and support GCP inspections, worldwide. Under… more
