- Insmed Incorporated (San Diego, CA)
- …with GTx Technical Operations and CDMOs, associated vendors and contracted laboratories.Apply Quality Risk Management for key processes and systems. Identify ... agency inspections, working with regulators, and vendor/supplier audits.Broad knowledge of risk -based quality systems approaches consistent with ICH Q10 for… more
- Tris Pharma (Monmouth Junction, NJ)
- …implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and resolution) ... knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience with drug-device combination… 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)
- …data may be shared with the relevant business functions teams within the DS organization. Risk -based Quality Oversight. Contribute to the measurement of DS KPIs / ... immune disorders. SUMMARYProvide support to the Global and Regional Quality Leads, External Partner Quality Leads, and Business Partner Quality Leads based… more
- Merck & Co. (Durham, NC)
- …skill sets in planning / scheduling, and time management.Experience with Quality Risk Management.Experience with Deviation Management.Experience with Kneat, ... product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.The Quality Assurance Manager will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …members for each study. Establish appropriate work procedures/guidance, logs, templates, quality procedures, risk impact assessment mitigation procedures, to ... areas centered around rare diseases and immune disorders. Job Summary: The Manager , Clinical Data Repository Administration is a member of the Biostatistics and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and external ... abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensuring that all stakeholders are aligned and informed. Ultimately, the Content Project Manager plays a critical role in delivering high- quality digital content ... A WEEK, IN OFFICE IS REQUIRED The Position The purpose of the Content Project Manager role is to oversee and manage the execution of content projects from strategy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and indirect compliance, handling state tax audits and notices, evaluating state tax risk , and ensuring realization of state credits and incentives for all Novo ... internal stakeholder relationships to gain business understanding and provide expert quality deliverables. This includes securing an understanding of acquired assets… more
- Merck & Co. (Durham, NC)
- …change controls. Approve cleaning validation documentation as needed. May act as a Quality Risk Assessment Lead. - - Education Minimum Requirement: High School ... or drug product. GMP experience with qualification of equipment. Experience with Quality Risk Management. Project Management experience in a highly regulated… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …process validation, computer system validation and calibrationPerform functional and process risk assessments in conjunction with Quality and Manufacturing ... support of commercialization. Serve as a technical resource to improve product quality , reliability, and process capability. Support manufacturing to satisfy the … 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)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Medical Coding is accountable for delivery of medical coding services for ... teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality coding deliverables are on time to support drug development processes and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …The Quality Engineer will participate in Internal Audits as directed by the Quality Manager . In addition, the Quality Engineer will lead continuous ... addressing risk in process validations, and continues with overseeing risk using statistical quality control during manufacturing. In addition, addressing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …project plans across functional teamsDefines the interdependent deliverables and ensures that quality , risk , cost, time are managed within the overall approved ... discipline and its application to drug development required to deliver time, cost, quality , and risk management to teams.Demonstrated results in creating and… more
- Merck & Co. (Durham, NC)
- Job DescriptionSenior Specialist, Quality Systems and ComplianceOur company is expanding its global recombinant vaccine production network by investing and adding a ... the vaccine, comprised of fermentation, microfiltration/ultrafiltration, and chromatography steps.The Quality Senior Specialist provides expertise in the coordination of… more
- Merck & Co. (Durham, NC)
- …or drug product. GMP experience with qualification of equipment. Experience with Quality Risk Management. Project Management experience in a highly regulated ... Job DescriptionPosition Description: Senior Specialist, Quality Assurance Our Company will construct a new...objectives. Consults on an as-needed basis with next level manager on more complex decisions. Position Qualifications: Education Minimum… more
- Novo Nordisk Inc. (Virginia, WA)
- …with superior ability to lead through change. Relationships Internally, the Educator Manager (EM) reports to a Region Business Director (RBD) in the Commercial ... influencing diabetes and obesity care (eg, diabetes centres of excellence, quality , care management, population health, and other key departments focused on… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …related to government reporting obligations, such as Aggregate Spend and Risk Evaluation and Mitigation Strategy (REMS) including the management and oversight ... Implements and oversees automation processes to improve data reviews and data quality for ensuring government obligations Tracks all policy and contract template… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Change Management process. Through careful coordination with stakeholders and consistent quality assurance, minimize the risk of changes, strive for ... centered around rare diseases and immune disorders. Summary The ITSM Process Manager for Change Management is responsible and accountable for managing and… more
