- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and implement modifications to risk assessment plans. Key Responsibilities Follow QRM ( Quality Risk Management ) process per ICH Q9, identify the ... Therapy Manufacturing Plant. In addition, the candidate must have Quality Risk Assessment experience in the pharmaceutical...based on failure analysis results. Plan and implement Risk Assessment, support define Risk Assessment scope,… more
- Merck & Co. (Rahway, NJ)
- …incumbent is responsible to support the operational functions of the Third Party Quality Management group, which provides quality oversight of suppliers ... initiatives for profiled and platform vendor base,Operational execution for phase appropriate, risk based processes for third parties' performance oversight and… more
- Merck & Co. (Rahway, NJ)
- …sterile processing and sterility assurance practices and guidelinesStrong experience with QRM ( Quality Risk Management )Strong working knowledge of SDLC, GAMP ... Requirements For Education, Experience And Skills)Job Description:The Associate Director Quality Assurance, Facilities, Validation & Automation will provide … more
- Merck & Co. (Durham, NC)
- …QA support to assigned areas of focus including but not limited to quality risk management , strategy development, development/revision of standard operating ... in a fast-paced environment.Aseptic manufacturing and GMP quality experience.Experience with Quality Risk Management and strong contemporary knowledge of… 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)
- …country program rollout with cross divisional and market stakeholdersStrategic thinking, risk management , and roadmap planning for data product evolutionEnsure ... Job DescriptionPosition Description: Associate Director Data Product Management Job Description We are seeking a strong, highly energetic and collaborative leader to… more
- Merck & Co. (Durham, NC)
- …investigations as needed and follows site procedures in the documentation of Quality Notifications and CAPAs within the deviation management program.Provides ... Job DescriptionOur Quality Assurance group ensures every single material inside...raw material and component testingOther duties as requested by management . Education requirements: BS or BA degree in Science… 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...maximise audits conducted during one trip ie grouped audits based on location Development of metrics to provide visibility… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Assessment and Prioritization: Conduct risk assessments to prioritize investigations based on potential impact on product quality , patient safety, and ... Management will provide strategic direction and leadership for the investigations management system. Working closely with the Quality Senior Manager, this… more
- Eisai, Inc (Nutley, NJ)
- …stakeholders from EIT and leaders across regions in Compliance, Ethics, Risk Management , Legal, Data Privacy, and Information Protection.Security ... recovery testing.Regularly review adherence to standards.Oversee regional security vendors.Prioritize risk - based reduction efforts.Manager investigations.General Compliance Activities:Maintain an… 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …execution and controlling Knowledge, Skills, and Abilities: Strong knowledge of project management planning, risk , and financial management tools Ability ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...for incumbent in this role. This is an onsite based role with relocation assistance eligible for selected candidate.… more
- Merck & Co. (Rahway, NJ)
- …(including the CTC, CRAs and COM). Responsible for creating and executing a local risk management plan for assigned studies. Ensures compliance with CTMS, eTMF ... issues and training needs to CRA manager and/or functional vendor and internal management as needed. Performs Quality control visits as required. Leads local… more
- Merck & Co. (Rahway, NJ)
- …in specific Quality systems, technology platforms, regulatory expectations and/or EE management , and can represent the Company in forums on their area of ... site associated with the manufacturing of company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution of the… more
- Novo Nordisk Inc. (South Houston, TX)
- …the diabetes educator will interact with key health system departments including: quality , care management , population health, diabetes treatment centres, and ... relationships with key decision makers responsible for the direct management and care for the "at risk "...Deeper understanding of Advanced Alternative Payment Models and other quality incentives that are focused on value- based … more
- Merck & Co. (Durham, NC)
- …Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain Capital project management experience Risk Management experience Experience ... make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant… more
- Merck & Co. (Rahway, NJ)
- …development, stakeholder communication, total cost of ownership, user satisfaction, product quality and realizing measurable outcomes across the product line. They ... scope include general ledger, fixed assets, projects, operating expense management , financial close, consolidation, intercompany profit, and financial data… more
- Merck & Co. (Rahway, NJ)
- …specified-timelines with minimal oversight from the line manager.-Ability to proactively develop risk management and mitigation plans in the country and-resolve ... with ICH/GCP and country regulations, company policies and procedures and-with quality standards internally and externally.Under the oversight of the CRD(Clinical… more
