• Insmed Incorporated (San Diego, CA)
    …effectiveness of the Quality departmentAssist in other quality assurance related activities as agreed with management .Knowledge & Experience7+ years ... similar function.Full understanding of GMP and Gene Therapy manufacturing.Familiarity with Quality Assurance aspects in manufacturing processes of new… more
    HireLifeScience (02/14/25)
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  • Exela Pharma Sciences, LLC (Lenoir, NC)
    …root cause investigations into microbiological and manufacturing process nonconformances.Assist Sterility Assurance and Quality management during routine ... should be able to work with direction from Sterility Assurance Management to uphold the policies and...to coordinate project execution and to work alongside Sterility Assurance , Quality , and Operations personnel to ensure… more
    HireLifeScience (01/03/25)
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  • Formation Bio (New York, NY)
    …bring new treatments to patients faster and more efficiently.About the PositionThe Director, Quality Management Systems plays a pivotal role in ensuring ... establishment and continuous improvement of an effective, compliant and 'fit for purpose' quality management system (QMS) ensuring Formation Bio is in a phase… more
    HireLifeScience (02/26/25)
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  • Tris Pharma (Monmouth Junction, NJ)
    Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team to ... biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines that address unmet... principles in the design (and resolution) of key quality management system elements to ensure complianceTracks… more
    HireLifeScience (01/31/25)
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  • Cytiva (Pensacola, FL)
    …and drive customer-centric solutions during change management initiatives.Team Development & Performance: Build a high-performing quality department, ... Director Filtration - Membrane Sites and leads both the Quality Control and Quality Assurance ... Leadership & Compliance: Serve as the Pensacola site's Quality Management Representative, leading QA/QC functions, ensuring… more
    JobGet (03/18/25)
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  • Merck & Co. (North Wales, PA)
    …to anticipate stakeholder requirements.Preferred Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong ... a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter… more
    HireLifeScience (03/14/25)
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  • Twist BioScience (South San Francisco, CA)
    …Engineering, Biomedical or Biological Sciences, or a related field.10+ years of experience in quality assurance or customer service, with at least 5 years of ... We are seeking a highly experienced and motivated Staff Quality Engineer join our dynamic team. As a Staff...experience in a supervisory or management role.Proven ability to lead and manage projectsStrong analytical… more
    HireLifeScience (12/24/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with Quality ... and updates Study Supply Plans in close communication with CSO project Management Lead.Responsible for the Clinical Label Development process which includes… more
    HireLifeScience (02/11/25)
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  • Formation Bio (New York, NY)
    …new treatments to patients faster and more efficiently.About the PositionThe Sr. Director, GMP Quality Assurance will lead the GMP QA strategy and execution for ... availability for trials. Establish and maintain 'fit for purpose' GMP related quality assurance procedures processes, and documentation to ensure the consistent… more
    HireLifeScience (02/26/25)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …in support of site improvement projects and strategies.Be a Subject Matter Expert on quality assurance topics within the group in support of QC lab ... candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell… more
    HireLifeScience (02/13/25)
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  • Novo Nordisk Inc. (West Lebanon, IN)
    …Contribute to the development of tools/techniques to enhance the project management processes Ensure compliance with the Quality Management System ... closely with Engineering, Manufacturing, Facilities, Manufacturing Sciences & Analytical Technology, Quality Assurance , Quality Control, and Validation, on… more
    HireLifeScience (03/06/25)
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  • Genmab (Plainsboro, NJ)
    …or the US. Main responsibilities include:Provide QA leadership to the global Quality Assurance team at Genmab.Strengthen and develop the QA organization's ... compliance with the department budget.Communicate specific QA results/trends to development management and superiors on an ad...or health-related field.Minimum of 15 years of experience in Quality Assurance across all GxP related areas… more
    HireLifeScience (02/25/25)
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  • Insmed Incorporated (San Diego, CA)
    …expertise with global counterparts in other functional areas such as Clinical Development , Regulatory Affairs, Quality Assurance , Medical Affairs, Marketing, ... risk management , and risk communication for assigned gene therapy development products as well as medical assessment of individual adverse event reports,… more
    HireLifeScience (02/26/25)
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  • Tris Pharma (Monmouth Junction, NJ)
    …regulatory requirements and guidelines for clinical trialsHands on experience with data management and quality assurance processesExperience interacting with ... knowledge of regulatory requirements and guidelines for clinical trialsExperience with data management and quality assurance processesAbility to potentially… more
    HireLifeScience (03/14/25)
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  • Exela Pharma Sciences, LLC (Lenoir, NC)
    …qualification, packaging and labeling. This position will interface with Operations, Regulatory, Quality Assurance , Finance, R&D, Project Management and ... process.Direct and coach cross functional team staff in areas such as quality , compliance, safety, project planning, process development , technology … more
    HireLifeScience (02/02/25)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …organization working closely with local, regional and global stakeholders across the Quality Assurance organization and with members from different business ... quality related process, define strategies to lead to the development and implementation of quality improvement initiatives across the organization.This… more
    HireLifeScience (03/08/25)
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  • Merck & Co. (North Wales, PA)
    … conceptsExperience in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ... Sciences), a distinguished department within our renowned Research and Development division, quantitative scientists, in partnership with other subject matter… more
    HireLifeScience (03/11/25)
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  • Twist BioScience (South San Francisco, CA)
    …uncover non-obvious needs.Incorporate quality into product design, and work closely with development and software quality assurance teams on product and ... towards Operational Excellence.Have experience using and/or managing Lab Information Management Systems (LIMS) and Manufacturing Execution Systems (MES).Have strong… more
    HireLifeScience (02/11/25)
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  • Merck & Co. (North Wales, PA)
    …The incumbent will collaborate closely with various stakeholders, including Analytical Development , External Capabilities, Quality Assurance , Technical ... or related scientific field with 3 years of relevant experience in analytical development , validation, and/or quality control, or MS degree with 1+ year… more
    HireLifeScience (03/13/25)
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  • Merck & Co. (North Wales, PA)
    …-The incumbent will collaborate closely with various stakeholders, including Analytical Development , External Capabilities, Quality Assurance , Technical ... or related scientific field with 3 years of relevant experience in analytical development , validation, and/or quality control, or MS degree with 1+ year… more
    HireLifeScience (03/13/25)
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