- Merck & Co. (Durham, NC)
- …drug substance or drug product.GMP experience with qualification of equipment.Experience with Quality Risk Management .Project Management experience in ... project proceed in compliance with cGMP, regulations, and our Company's Quality Management System.Supporting areas such as Design, Commissioning, Qualification… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a continued practice centered on Quality by Design, Clinical Trial Risk Management , efficient Issue Management , and Continuous Improvement.Supports SVO ... and oversee the CTOR team who support GCO Quality by Design, risk and issue management . This team will also be responsible for creating and managing tools to… more
- Novo Nordisk Inc. (WA)
- …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
- Russell Tobin & Associates (New Albany, OH)
- …products. Requirements: Entry-level position; previous experience is preferred. Experience in quality planning, project management , quality control ... What are we looking for in our Quality Engineer? The Scientific Team at Russell Tobin...near New Albany, OH! Responsibilities: Assist in new project risk assessment (product, design, package, formula, etc.) to evaluate… more
- Metasys Technologies, Inc. (New Albany, OH)
- …Evaluate test data for compliance. Support QA Lab with first production submissions. Quality Control Issue Management (50%) Provide root cause analysis to ... include preparing and maintaining detailed reports and analyses, supporting risk assessments for new projects, and assisting in the... assurance is preferred but not required. Knowledge of quality planning, project management , quality … more
- Careerbuilder-US (Rocklin, CA)
- …Description: Roles that are responsible for the analysis, development, and operation of quality and risk management systems. Activities include developing ... team and responsible for providing quality support for the site quality management system. This position ensures compliance of the quality system with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality Assurance, Medical ... and the business users to define user information needs.Provide informatics project management , SDLC Quality Model expertise, and computer system validation… more
- Aequor (Thousand Oaks, CA)
- …development and commercial lifecycle maintenance, product stability programs, CMC regulatory filings, risk assessment, and Quality Management Systems. offers ... oversight of the product stability programs, providing indirect staff management and guidance to members of the PQT. Key...filing sections and RTQs? Provide expertise in science and risk -based evaluation of complex process and product quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. Summary The Manager, Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible to ... best practices to help facilitate the inspection readiness mindset.Facilitates clinical quality risk identification and the necessary problem solving and… more
- Aequor (Irvine, CA)
- …in project management , data analysis, root cause analysis, communication, and risk determination Ensure compliance with the company's Quality System policies ... and analyses product performance of medical devices using a statistical and risk -based approach. Considers any quality , compliance, customer, and business risks.… more
- Merck & Co. (Durham, NC)
- …in a timely manner for proper resolution to ensure product qualityPROJECT MANAGEMENT :Accountable for quality and/or technical contribution to project team or ... componentsUnderstands quality systems relevance and importance when developing quality policies, SOPs and guidelinesRESOURCE MANAGEMENT :Aware of costs and… more
- Dexian - DISYS (Rocklin, CA)
- …Description: Roles that are responsible for the analysis, development, and operation of quality and risk management systems. Activities include developing ... for providing quality support for the site quality management system. This position ensures compliance...reports o Summary of Safety and Performance reports o Risk Management plans, reports, FMEAs o Post-Market… more
- Catalent (Manassas, VA)
- …patient, consumer and Catalent employee. As an integral member of the Global Supplier Quality Management team, the Supplier Quality Regional Lead will be ... in support of supplier integrity and oversight. The Supplier Quality Regional Lead will oversee management of...communication of common finding categories to allow identification of risk areas across Supplier base Proactive planning to ensure… more
- Catalent (St. Petersburg, FL)
- …Supplier Quality Director approval Act as a liaison between suppliers and the quality teams globally during the management of supplier quality issues ... Quality Auditor Position Summary: Catalent is a global,...be p erforming audits, generation of audit reports and management of supplier CAPA to ensure required actions are… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas (eg clinical research & development, clinical science, clinical quality assurance, project management ) preferredStrong leadership, collaboration, ... Director, Global Clinical Operations (GCO) Procedural Ownership and Life Cycle Management , will be accountable for the authoring and lifecycle management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …map to meet changing regulatory and business needs.Lead remediation and risk management to assure the organization's Quality Management System is robust ... direction and collaboration with Global External Supplier QA teams.Collaborate with Global Quality Management System (QMS) teams on regulatory-related CAPAs that… more
- JobsRUs (Rocklin, CA)
- …Description:Roles that are responsible for the analysis, development, and operation of quality and risk management systemsActivities include developing ... team and responsible for providing quality support for the site quality management systemThis position ensures compliance of the quality system with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.- Define and implement ... for overall product safety strategy or specific areas of safety surveillance and risk management , and provide safety leadership including but not limited to… more
- Novo Nordisk Inc. (Durham, NC)
- … Operate within compliance with a Quality Mindset that focuses on risk management & mitigation Implement effective Change Management Support Corporate, ... our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate… more
- Option Care Health (Chicago, IL)
- …integrated reviews and process assessments with other functions, such as Legal, Internal Audit, Quality & Risk Management , Revenue Cycle Management , ... Analytics is responsible for overseeing and conducting the Compliance program's risk -based auditing, monitoring and analytics activities to monitor, assess, and… more
