- Tris Pharma (Monmouth Junction, NJ)
- …skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience with drug -device combination products (highly ... Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality … more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.Genmab is seeking a Clinical Drug Supply Manager to join our Global Clinical Drug Supply ... locations to work according to our hybrid work arrangement.Responsibilities/tasks:Act as Clinical Drug Supply Manager , of the following tasks:Global Clinical … more
- Genmab (Plainsboro, NJ)
- …to fulfilling our purpose.The Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical Drug Supply ... Operations team.As Senior Clinical Drug Supply Manager you will play a pivotal role in ensuring...a pivotal role in ensuring the timely delivery of high- quality clinical trial supplies for both early and late-stage… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the Quality team based ... in Raritan, NJ. Role OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production of autologous CAR-T products for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a project manager /leader in planning and executing strategies for global drug development: early stage, late stage and life cycle management preferred10 or More ... Sr Director GPM&L is accountable for delivering an integrated drug development strategy and tactical plan including options analysis...to ensure delivery of projects within cost, time and quality requirements. As a leader in GPM&L this position… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a QA Batch Warehouse Associate Manager as part of the Quality team based in Raritan, NJ. Role ... the QA oversight of Warehouse activities. This position is responsible for quality and maintaining the highest standards in compliance within company policies,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Laboratory Compliance Manager role is an exempt level position with responsibilities...is an exempt level position with responsibilities for providing quality oversight over the compliance program for the site… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensure high quality coding deliverables are on time to support drug development processes and global submissions. This position also partners with internal and ... areas centered around rare diseases and immune disorders. Job Summary: The Manager , Medical Coding is accountable for delivery of medical coding services for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on ... Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and external stakeholders communicating project… more
- Merck & Co. (Durham, NC)
- … product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.The Quality Assurance Manager will ... on Day Shift before transitioning to 2nd Shift Preferred Experience and Skills: GMP quality experience with media, biological drug substance and drug … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …industry.Excellent knowledge of project management discipline and its application to drug development required to deliver time, cost, quality , and ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Senior Project Manager , PMO as part of the Technical Operations team based in Raritan,… 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 ... We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks related to final printed pharmaceutical… more
- Merck & Co. (Durham, NC)
- …production of commercial product.- The focus for the position includes all aspects of Quality oversight for drug product, drug substance, media preparation, ... Preferred Experience and Skills: Prior Change Control and Deviations Management experience GMP quality experience with biological drug substance or drug … more
- Merck & Co. (Durham, NC)
- …of commercial product.- The focus for the position includes all aspects of Quality oversight for drug substance, media preparation, and sterile supply. The ... Demonstrated ability to work in fast-paced, complex environments and escalate appropriately. GMP quality experience with biological drug substance or drug … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing, ... the team has the necessary tools, infrastructure, and support to deliver high- quality AI solutions. Provide mentorship and guidance to individuals and teams on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with Quality Assurance ... investigational product distribution activities at the vendor, including generation of drug orders, review of shipping documentation and obtaining approval to… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description: The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and approval ... Primary responsibilities include but are not limited to the following: Perform quality assurance activities related to API (including new modalities such as ADCs)… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead auditor Works ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...years of direct QA experience Experience in a licensed drug or biologic facility regulated by the FDA, EMEA… more
- Fidelity Investments (Boston, MA)
- Job Description:Senior Manager - Global Financial Controls Center of ExcellenceThe Global Financial Controls Center of Excellence (GFC-CoE) is an enterprise-wide ... advisory services for select strategic initiatives and modernization efforts.The Senior Manager role will deliver significant value to the business by leading… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to multiple aspects of ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted… more
