- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director, Data Quality and Integrity (Global R&D & PV QA) ensures high ... standards of data quality and compliance within Global R&D...to foster a culture of compliance and accountability in data management practices. The position also involves… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming ... reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements. Oversees the execution of… more
- Genmab (NJ)
- …fit? Then we would love to have you join us!The RoleThe Associate Director, External Data Quality Management , is a strategic leadership role within Clinical ... with external vendor management a plus.Proven expertise in protocol design, data quality management , and protocol deviation oversight.Strong knowledge of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the drug development process.Collaborates within the function and cross-functionally to resolve issues pertaining to data management in clinical trials ... to ensure data quality /integrity and regulatory complianceEnsures that Data Management Plans are consistent and regulatory compliant across studies and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in support of clinical development objectives.- Accountable for lab data management deliverables for all programs meeting quality and time expectations for ... oversight of CROs pertaining to laboratory data management , LNR collection standards, and quality issue...expertise in the resolution of lab related inquiries and issues such as conversion factors, translations, and textbook ranges.-… more
- Tris Pharma (Monmouth Junction, NJ)
- …Tris has an immediate opening for a SR. Manager or Manager, Quality Management Systems (QMS). Title commensurate with experience.Summary:This position supports, ... management principles in design (and resolution) of key quality management system elements to ensure complianceTracks... quality systems by identifying and proactively resolving quality issues Develops, analyzes and compiles … more
- Merck & Co. (Rahway, NJ)
- …and our company's requirements while driving continuous improvement in Device Supplier Quality Management .- Accountable for other Quality Programs, as ... are compliant.Participates on our teams supporting MDCP cGMP and quality issues related to pure Medical Devices...820, EU MDR:2017/745, and ISO 13485:2016 for review of Quality Management System documents for the … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …experienced quality representatives and/or contingency workers. Essential Functions Deviation Management Develops and serves as Quality Point of Contact for ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Aequor (Thousand Oaks, CA)
- …actions, procedures revision, Training portfolio, monitoring and revising SAP Mater data Quality Inspection plans, and projects implementation plan. Will ... of equipment in area of expertise. 15. Extensive knowledge and application of SAP Quality Management (QM) Module 16. Advanced skills in solving complex problems.… more
- Merck & Co. (Rahway, NJ)
- …Pharmaceutical Management , Pharmaceutical Manufacturing, Process Improvements, Quality Management Systems (QMS), Regulatory Inspections, Regulatory ... Oversee the Compliance, Remediation, and Support (CRS) team within Global Quality Compliance Support. Provide compliance leadership and direction to our company… more
