- 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
- The University of Vermont Health Network (Plattsburgh, NY)
- …and minimize patient wait time. They are responsible to perform operational and quality / risk management duties according to regulations and protocols. The ... commitment to CVPH core values of teamwork, commitment, confidentiality and quality care.4. Excellent attention to detail.5. Good written and verbal communication… more
- Merck & Co. (Rahway, NJ)
- …with understanding of Design Controls (21 CFR 820.30)Familiarity with the following standards: Quality Management - ISO 13485, Risk Management ... (FMEA, DFMEA).Liaises closely with other partner functions including QA ( Quality ), Analytical Sciences, CROs and others to support project timelines.Cross-functional… 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
- 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
- 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
- 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
- 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
- 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
- Merck & Co. (Durham, NC)
- … system initiatives and continuous improvements.-Core responsibilities:Supports the deviation management program including the coordination of managing Quality ... application of cGLPs and cGMPs.Experience with batch release, and quality systems management ;-Preferred qualifications:Preferred Experience and Skills: Strong… more
- Merck & Co. (Rahway, NJ)
- …Portfolio, Programme, and Project Support, Program Management , Project Management , Risk Management , Stakeholder Relationship ManagementPreferred ... ensure that releases are delivered on time, within budget, and with minimal risk .The Release Management Senior Specialist is responsible for the following:Work… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Management will provide strategic direction and leadership for the investigations management system. Working closely with the Quality Senior Manager, this ... the Quality Associate Director to co-lead the deviation investigations management system. Ensure alignment with GMP regulations and organizational objectives in… more
- Insmed Incorporated (San Diego, CA)
- …functional and cross-functional teams and ad hoc project team meetings Conducts the risk management and scenario planning and develops contingency and/or risk ... Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Program Management , the Associate Director, Program Management supports the… more
- UT Health Tyler (Tyler, TX)
- …regarding Quality Monitoring and Improvement, Regulatory Compliance, Patient Safety, Risk Management , Medical Staff Services and Practice Standardization and ... safety event classification process. Provides collaboration and consultative support to Risk Management , Compliance, Medical Staff, Nursing, and others by… more
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