- Formation Bio (New York, NY)
- …defending it during health authority audits.Responsibilities Develop, implement, and maintain the pharmaceutical quality management system (QMS) to ensure ... and ICH guidelines. Proven experience in developing, implementing, and managing pharmaceutical quality management systems, including document control,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …topics to a non-technical audienceAt least 8 years' experience in the biotech/ pharmaceutical industry in validation, quality management , process controls, ... support of commercialization. Serve as a technical resource to improve product quality , reliability, and process capability. Support manufacturing to satisfy the … more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management ... principles in the design (and resolution) of key quality management system elements to ensure complianceTracks...in science or related field and minimum 6 years quality and/or cGMP compliance experience in the pharmaceutical… more
- Novo Nordisk Inc. (Durham, NC)
- …confirmation on shop floor Ability to support all processes & functions in Department Quality Risk Management Make decisions on quality & compliance issues ... or API, utility &/or packaging systems experience required, preferably in the pharmaceutical industry Demonstrated expertise in Regulations & quality systems… more
- Novo Nordisk Inc. (Durham, NC)
- …confirmation on shop floor Ability to support all processes & functions in Department Quality Risk Management Makes decisions on quality & compliance issues ... 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
- Novo Nordisk Inc. (Durham, NC)
- …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 ... three pharmaceutical manufacturing facilities that are responsible for fulfilling different...planning and development of maintenance and calibration personnel Ensure quality items and project deliverables are completed timely Facilitate… more
- Novo Nordisk Inc. (Durham, NC)
- …the Batch Review Processes required Understanding of validation preferred Understanding of quality management systems required Understanding of quality ... oversight & on floor production support required Knowledge in Quality Management Systems required Demonstrated knowledge of critical controls & input/output… 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 to ... reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements. Oversees the execution… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by the GQLs, EPQLs, and BPQLs, to internal and external stakeholders of R&D Quality .Support the oversight and management of CAPAs by tracking and following up ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...quality reports and outputs (JOC, QRB, QQRs, EMR).CAPA Management Support the oversight and management of… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …SummaryThe Quality Director is the senior leader and decision maker for the Quality Department and Quality Management System. This position is ultimately ... standards. This position is the decision maker for the Quality Management System deployed throughout the company....ten (10) years working experience in the medical or pharmaceutical manufacturing industry is Required. In addition, a minimum… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and offers an exceptional gateway to the fascinating world of fast-paced pharmaceutical manufacturing. The Quality Execution Coordinator will gain unprecedented ... Quality Execution CoordinatorPosition Summary:The Quality Execution Coordinator is...access to Company's senior management and become an integral part of… more
- Insmed Incorporated (San Diego, CA)
- …in other quality assurance related activities as agreed with management .Knowledge & Experience7+ years experience in Pharmaceutical Industry in a ... with GTx Technical Operations and CDMOs, associated vendors and contracted laboratories.Apply Quality Risk Management for key processes and systems. Identify… more
- Novo Nordisk Inc. (Durham, NC)
- …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 ... three pharmaceutical manufacturing facilities that are responsible for fulfilling different...recommendations and delivering results in the areas of energy management , capital budget planning and management , and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …maintain strategic integrated GOMA Franchise project plans, project timelines, high quality risk management plans, and communication plans, as needed.Operational ... requiredadvanced degree preferredExperience Qualifications7 or More Years experience in project management with at least five years in pharmaceutical industry… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... to ensure delivery of projects within cost, time and quality requirements. As a leader in GPM&L this position...for the accuracy of project status in the project management information systems, for preparing scope change proposals and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Qualifications: 7 or More Years of related experience, including Project Management , Clinical Supply Management , and/or Pharmaceutical Development. ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...This role is primarily responsible for supporting CSO Project Management Leads by developing and updating Study Supply Plans,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking an Quality Control Testing Scheduler as part of the Quality team based in Raritan, NJ. Role OverviewWe are seeking a detail - oriented ... and highly organized QC Testing Scheduler to join our team for Quality Control. The ideal candidate will manage and maintain our automated scheduling system,… more
- Formation Bio (New York, NY)
- …and documentation to ensure the consistent production of safe, effective, and high- quality pharmaceutical products. Cultivate support and commitment across other ... abreast of changes in regulations, guidelines, and industry trends related to pharmaceutical quality assurance and proactively implement necessary updates to the… more
- Merck & Co. (Rahway, NJ)
- …of molecules, intermediates, and degradation products to identify potential critical quality attributes.-The incumbent must be able to set strategy and enhance ... our organization's network. They will be responsible for all aspects of people management and talent development for personnel under their supervision. The role will… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …option 14 weeks Paid Parental Leave Free access to Novo Nordisk-marketed pharmaceutical products At Novo Nordisk, you will find opportunities, resources and ... to cGMPs, established manufacturing practices and procedures, and compliance with quality regulations and guidelines. QC Technician levels I - III depending… more
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