- Tris Pharma (Monmouth Junction, NJ)
- …of clinical study processes and procedures ensuring timely execution of quality clinical trials complying with all regulations and/or guidance. Collaborating ... the clinical development portfolio. The incumbent is accountable for the Clinical Operations cross functional collaboration to develop program strategy and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... study; Consults with KOLS for advice on complex development or safety issuesScientific, Program related: Integrated Study Team (IST) representative… more
- Catalent (San Diego, CA)
- …AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. As a member of ... Manager to create and sustain a site culture of Safety , Quality performance, Operational Excellence, continuous improvement,...Reviews, etc. and oversee and execute all Performance Management Program (PMP) actions for the site Quality … more
- Catalent (San Diego, CA)
- …from the best. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and ... Quality Assurance Associate II - Manufacturing Catalent Pharma...manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit… more
- Insmed Incorporated (Bridgewater, NJ)
- …disease experience preferred.Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/ submissions involving ... and on the market.Accountable for the delivery of high quality and timely medical safety deliverables. Provides...safety review input into all critical documents for clinical development of products (eg, protocols and amendments, ICFs,… more
- Catalent (Philadelphia, PA)
- …our facilities. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and ... initiation date.Release batch within scheduling database.Communicates SQDC countermeasures and safety issues to Quality Management.Ensures QADC metrics are… more
- Catalent (Manassas, VA)
- …maintain, validate and help revise annually the HACCP Plan, SQF Code, Gimbal's SOP and other Quality Program ; Ongoing Food Safety and Quality Program ... Assurance Supervisor will lead Food Safety and Quality programs. This includes implementation and on-going program...sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more… more
- Catalent (Philadelphia, PA)
- …our facilities. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and ... a QA Supervisor. The QA Supervisor will p rovide Quality Assurance support for the Quality Inspectors...Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... within quality systems processes. Key Responsibilities Lead the CAPA program for the CAR-T manufacturing site. Oversee metrics, trending, and reporting of… more
- Catalent (San Diego, CA)
- …from the best. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and ... Quality Assurance Associate I, ManufacturingCatalent Pharma Solutions in...manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit… more
- Catalent (San Diego, CA)
- …from the best.Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and ... Quality Control Chemist IPosition SummaryCatalent Pharma in San...manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit… more
- Catalent (Harman, WV)
- Position Summary The Director, Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... management, CAPA tracking, change control, risk management, supplier quality , audits and inspections, raw materials release, and compiling, trending and reporting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers, etc.) Clinical Safety , CROs and External Vendors ... perform validation of the electronically transmitted external data by ensuring all clinical & companion diagnostics data meet quality requirements and protocol… more
- Insmed Incorporated (Bridgewater, NJ)
- …Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance and Medical/ Clinical Departments. The incumbent will ... Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA serves as… more
- Catalent (Harman, WV)
- Position SummaryThe Head of Quality -Maryland is responsible for setting the strategic direction, properly staffing, and maintaining the Quality Management ... Patient First culture at the site. The Head of Quality -Maryland is responsible for Quality , Validation and...benefits effective day one of employment Tuition Reimbursement GymPass program to promote overall physical wellness Perkspot - offers… more
- Merck & Co. (Rahway, NJ)
- …2 years of management responsibility and experience developing staffFluency in the clinical quality management system and CMC process, across modalities and ... siting and compliance councils. Key performance indicators range from quality and regulatory compliance, operational excellence, pipeline program support,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …solutions to mitigate or resolve, for example across various topics, such as clinical trial management, deviation handling, and product quality Develop, execute, ... as a Novo Nordisk representative in interactions with Health Authority Inspector(s) at clinical trial sites Support local/global quality projects to improve the … more
- Merck & Co. (North Wales, PA)
- …of statistical databases that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.The position is ... quality , compliance and timeliness requirements.-Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems… more
- Insmed Incorporated (Bridgewater, NJ)
- …internal and external stakeholders (therapeutic areas, clinical pharmacology, clinical operations, non- clinical safety , contract research organizations ... for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large… more
- Catalent (Philadelphia, PA)
- …our facilities. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and ... in Philadelphia, PA is hiring a QA Inspector. This position reports to the Quality Supervisor. The Quality Inspector is responsible for process monitoring and… more
