- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in ... Raritan, NJ. Role OverviewThe Quality Systems Lead role is an exempt level position with responsibilities for supporting the quality systems processes within… more
- Insmed Incorporated (San Diego, CA)
- …leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on ... Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical Quality ...Quality Assurance, the Director of Clinical Quality Assurance (CQA) serves as a strategic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and ... around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation,… more
- Repligen (Waltham, MA)
- OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility which has proven experience in the biotechnology ... industry. This leader will be responsible for managing the site quality assurance team which includes all day-to-day activities for product manufacture, test and… more
- Merck & Co. (Rahway, NJ)
- …compliance activities such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead and/or ... Job Description Job Description The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and approval… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …leverages external expertise in supporting RBQM activities.- Technical: Provides technical guidance in Quality by Design. Lead the team to define Critical to ... Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision and strategy for the...targeted source document verification and targeted source data review. Lead the team to develop and implement metrics including… more
- Merck & Co. (Rahway, NJ)
- …set tactical and strategic direction on programs to ensure delivery of high- quality products, test methods, and robust manufacturing processes for both clinical and ... particularly in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products.The incumbent must be… more
- Merck & Co. (Durham, NC)
- …manufacturer? If so, then this is the opportunity for you! The Lead Maintenance Technician is responsible for providing equipment troubleshooting and maintenance ... an empowered team culture including significant interaction with Production, Technical Operations, Quality and other support groups.This is a day shift position, 12… more
- Repligen (Hopkinton, IA)
- OverviewThe Manufacturing Line Lead 2nd Shift reports to the Production Manager and helps in performing all tasks involved in the production of Repligen's fluid ... will play a key role in ensuring that the department's safety, quality , and production goals are met.ResponsibilitiesSupervise and coordinate the activities of… more
- BioAgilytix (Durham, NC)
- …That means hands-on work designing Azure Data Factory and API integrations, automating data- quality checks, and setting up clear governance so everyone knows who can ... keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data governance framework, with hands-on… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... difference? The Position Position is responsible for developing Quality and USO strategic objectives and strong business understanding of the value chain and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... difference? The Position Developing quality and strategic objectives and strong business understanding of...the business Demonstrate leadership skills via acting as project lead on cross-functional projects in the development and/or implementation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... difference? The Position Developing quality and strategic objectives and strong business understanding of the value chain and customer focus. This role enables and… more
- Merck & Co. (Durham, NC)
- …Mindset - Demonstrated ability to deliver compliant supply and achieve highest quality , lowest cost, and shortest lead -time. Strategic Thinking - Ability ... Vaccine Products. Our team works with a "Safety First, Quality Always" mindset.-As the primary point of contact for...and Activities include but are not limited to : Lead an Integrated Cross-Functional Team in Delivery of Reliable… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs ... Biostatistics Data Management & Data Ops for EDC, edit checks, data quality listings, SAP, Data Management plan; Reviews patient population and protocol compliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Medical Affairs Oncology Publications works with GMA Oncology Publications Lead , to develop publication plans, drive the execution of publication projects, ... organizations, and study investigators- Manage vendor budget and activities- Oversee the quality and timeline of vendor work- Collaborate with study clinical or… 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 ... Team Novo Nordisk and help us make what matters. The Position Serve as a Lead & Subject Matter Expert (SME) to provide technical expertise supporting site data and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile ... size.Responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will… more
- Aequor (Thousand Oaks, CA)
- …This "Specialist Manufacturing" role will serve as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital ... team at ATO B20. The NPI Lead is expected to have ownership over the Technology...value to the network: Manufacturing, Process Development, Supply Chain, Quality , and Facilities & Engineering. A high degree of… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …Team, the Vice President of Preclinical Research & Development will develop and lead the all of the Institute's Contract Research activities and functions to ... fostering innovation across Lovelace's scientific functional areas, specifically:Operational Leadership: Lead the seamless daily operations of Lovelace's research facility.… more
