- Insmed Incorporated (San Diego, CA)
- …they are accurately represented in current SOPs is essential.Broad knowledge of risk-based quality systems approaches consistent with ICH E6 for Good Clinical ... Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the ... Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … risks.Technology & Automation: Familiarity with modern manufacturing systems (MES, ERP, etc.) and digital transformation initiatives.#Li-BZ1#Li-HybridThe ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan,… more
- Merck & Co. (Rahway, NJ)
- …design verification testing, and process validation, with a strong understanding of quality management systems and regulatory compliance .Exceptional project ... products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team of engineers and technical… more
- Eisai, Inc (Nutley, NJ)
- …out routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for clinical area Strong analytical skills and report writing ... is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director...Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard… more
- Merck & Co. (Upper Gwynedd, PA)
- …Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC is ... responses to health authority questions per established business processes and systems .-Identify, communicate and escalate potential regulatory issues to GRACS CMC… more
- Merck & Co. (San Francisco, CA)
- Job Description Position Description: Associate Director , DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) ... interdependent across our functional areas, Discovery, our Manufacturing Division Quality , and BARDS, to name a few, and with...of the DSCS Digital Program Mgmt Lead, the Associate Director , DSCS Digital Project Manager, will be responsible for… more
- Tris Pharma (Monmouth Junction, NJ)
- …strategies and operations, contract negotiations, supplier relationship management, procurement systems functionality/workflows and assurance of compliance with ... systems to maintain optimal stock levels and minimize obsolescence; Ensures compliance with safety, quality , and regulatory standards in warehouse… more
- Merck & Co. (Rahway, NJ)
- …a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,- strategies and ... the efficiency, accuracy, and effectiveness of clinical supply planning processes and systems . - Stay updated on industry trends, regulations, and best practices… more
- Insmed Incorporated (San Diego, CA)
- …process development support testing function within analytical development. Will develop systems and processes to facilitate rapid, high throughput testing. As the ... on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take care of the… more
- Merck & Co. (Rahway, NJ)
- …Standard Operating Procedures (SOP) and current GXP documents.Experience with quality systems .Excellent organizational skills.Desire and willingness to learn, ... Data-Driven Decision Making, Drug Product Development, Estimation and Planning, GMP Compliance , Management Process, Manufacturing Quality Control, Medical Supply… more
- Twist BioScience (South San Francisco, CA)
- …MES professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance, and R&D. The Director will serve as the ... Sr. Director , Manufacturing Execution System (MES) (Hybrid in South...and data visualization capabilities to support operational decision-making and quality reviews. Compliance & Validation: Ensure our custom… more
- Eisai, Inc (Exton, PA)
- …close-out of documentation, manufacture of DS/ADI materials, and suite change-over ensuring compliance to relevant regulations. The Associate Director is also ... profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible...with other Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory, and CMC… more
- Merck & Co. (Durham, NC)
- …Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director ).-This role serves as a Virtual Plant Manager - responsible for leading a ... Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director , External Manufacturing Operations will also assist in commercialization… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cutting-edge AI/GenAI technologies and developing AI/GenAI products to deliver high quality insights with speed and efficiency Promotes a culture of creativity ... the Novo Nordisk US Operations, including ED&AA, IT, Ethics and Compliance , Commercial, Patient Services, CMR (Clinical, Medical, Regulatory), Finance, and Novo… more
- Repligen (Clifton Park, NY)
- …will play a key role in delivering the site expansion programs, implementing quality management systems and maintaining ISO certification. The individual will ... functions and have personal development plans.Ensure that the operation is in compliance with all aspects of Repligen's IS09001 Quality Management Responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role ... in overseeing the development, validation, implementation, and integration of GxP-regulated systems across the organization. This position ensures that all global … more
- Repligen (Hopkinton, IA)
- OverviewWe are seeking a Document Control/QA Associate I to join our growing Quality Department team in Hopkinton, MA for 1st shift operations (M-F) from 8 am EST - ... pm EST.The Document Control/QA Associate I will report directly to the QA/QC Director .This position is responsible to actively participate in the Repligen ISO 9001 … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …full alignment across internal and external stakeholders and partners Maintain robust compliance , quality and privacy standards in handling customer information ... NovoCare® Patient Support Programs. Management of relevant data sets include compliance and database information integrity, program tracking, metrics, analysis, and… more
- ThermoFisher Scientific (Indianapolis, IN)
- …impact:** Reporting directly to the Vice President, Quality , the Director , Quality - Digital Systems Compliance is responsible for ensuring that all ... and mentor a team of Quality professionals committed to computer systems compliance and validation of critical business systems . + Coordinate all aspects… more
- Olympus Corporation of the Americas (Redmond, WA)
- …upon to support Global Ship Hold activities. They support the Director , Site Quality Systems with ensuring compliance to the Quality Management ... Quality Engineer I is a role that provides Quality Engineering support to ensure compliance with...years minimum' experience operating in any Engineering position, preferably Quality Systems Engineering in a highly regulated… more
