- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Job Summary: This position is responsible for implementation and oversight of the Risk Based Quality Management (RBQM) principles that support ... vision including elements to achieve a Quality by Design (QbD) and Risk - Based Quality Management (RBQM) approach to clinical trial conduct. Major… more
- Novo Nordisk Inc. (Los Angeles, CA)
- … risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Aequor (South San Francisco, CA)
- …with the ultimate goal of driving data-driven decision-making throughout the study lifecycle. The Risk Based Quality Management (RBQM) Data Analyst sits ... RBQM workgroup members to develop and operationalize the integrated Quality Risk Management Plan (iQRMP)...Leads and other RBQM workgroup members. Deliver timely and high- quality risk - based monitoring analytics and… more
- Merck & Co. (Rahway, NJ)
- …and lifecycle management . This individual will oversee device risk management activities to ensure the delivery of high- quality products and efficient ... Job DescriptionThe Associate Principal Scientist, Device Risk Management Lead, is a crucial...experience in pharmaceutical development, device development, device systems operations, quality management , or a related area.Strong knowledge… more
- Merck & Co. (Rahway, NJ)
- …manufacturing and 10 years overall within biopharmaceuticals.Planning and facilitating high risk and highly complex Quality -related process reviews and/or ... Job DescriptionThe incumbent will be responsible for serving as the quality representative for, and providing quality oversight of, contractors performing… more
- Tris Pharma (Monmouth Junction, NJ)
- …recommend/ implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and ... in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management … more
- Merck & Co. (Rahway, NJ)
- …and Combination Product current Good Manufacturing ruling (21CFR part 4), Device Risk Management (ISO 14971) and other worldwide regulations and requirements. ... of a combination product.Review and approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development,… more
- Merck & Co. (Durham, NC)
- …skill sets in planning / scheduling, and time management .Experience with Quality Risk Management .Experience with Deviation Management .Experience with ... proceed in compliance with cGMP, regulations, and our Company's Quality Management System focusing on batch record...Hybrid Work Model Effective September 5, 2023, employees in office- based positions in the US will be working a… more
- Merck & Co. (Durham, NC)
- …drug substance or drug product. GMP experience with qualification of equipment. Experience with Quality Risk Management . Project Management experience in ... proceed in compliance with cGMP, regulations, and our Company's Quality Management System. Provide QA shop floor...cleaning validation documentation as needed. May act as a Quality Risk Assessment Lead. - - Education… more
- Merck & Co. (Rahway, NJ)
- …Support compliance activities such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead ... Job Description Job Description: The Rahway based Senior Specialist, Global Development Quality ...Experience in one or more functional areas such as quality assurance, laboratory, manufacturing, production, equipment/facilities management ,… more
- Insmed Incorporated (San Diego, CA)
- …with GTx Technical Operations and CDMOs, associated vendors and contracted laboratories.Apply Quality Risk Management for key processes and systems. ... agency inspections, working with regulators, and vendor/supplier audits.Broad knowledge of risk - based quality systems approaches consistent with ICH… more
- Merck & Co. (Durham, NC)
- …learning events, or business support initiatives, as guided or approved by Quality management .Train employees on new or revised processes or procedures.Review ... of technical and operational problems through collaboration with peers.Applies appropriate risk management while adhering to cGMP requirements.Makes decisions… more
- Merck & Co. (Durham, NC)
- …drug substance or drug product. GMP experience with qualification of equipment. Experience with Quality Risk Management . Project Management experience in ... proceed in compliance with cGMP, regulations, and our Company's Quality Management System. Supporting areas such as...Hybrid Work Model Effective September 5, 2023, employees in office- based positions in the US will be working a… more
- Merck & Co. (Durham, NC)
- …Laboratory Information Management System (GLIMS), Experience participating in Quality Risk Assessments (QRAs) Experience with calibration and maintenance ... Job DescriptionQuality Engineering (QE), part of Durham's Quality Assurance (QA) organization, in Building 160 (B160) is seeking a Quality Specialist (P2) that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere ... and reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements. Oversees the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data may be shared with the relevant business functions teams within the DS organization. Risk - based Quality Oversight. Contribute to the measurement of DS ... External Partner Quality Leads, and Business Partner Quality Leads based on assigned programs and...and BPQLs, to internal and external stakeholders of R&D Quality .Support the oversight and management of CAPAs… more
- Twist BioScience (South San Francisco, CA)
- …EU regulations for IVDRExperience with ISO 13485 and GMP requirements.Deep knowledge of Risk management and Design ControlExperience with Six Sigma or other ... We are seeking a highly experienced and motivated Staff Quality Engineer join our dynamic team. As a Staff...least 5 years of experience in a supervisory or management role.Proven ability to lead and manage projectsStrong analytical… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Merck & Co. (Rahway, NJ)
- …manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical ... engineering design, engineering analysis and testing, medical device design controls, risk management , test method/fixture development, design verification and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and reports, interpret results, and generate technical conclusions consistent with quality risk management principles.Recognize patterns and trends ... QA Lab Oversight Specialist I/II/III as part of the Quality team based in Raritan, NJ. Role...technical or scientific initiatives and activities.Routinely recognize and resolve quality issues. Seeks management guidance on complex… more
