- Eisai, Inc (Nutley, NJ)
- …(CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice ... is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director...and for-cause audits Knowledge of data integrity controls and systems quality for clinical area Strong analytical… more
- Merck & Co. (Rahway, NJ)
- …will: Execute solutions to business needs by designing and implementing new data management systems Employ innovation and technology solutions to manage data ... and WW regulations, company policies and Standard Operating Procedures.The Associate Director , Business Insights and Analytics (BI&A), is responsible for Developing… 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...our biomanufacturing operations. This critical role will drive efficiency, quality , and robust data integrity within a highly automated… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …operations management , tech transfer, process and equipment validation or quality management ; with a preference for Cell/Gene Therapy experienceMinimum of ... 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
- Eisai, Inc (Exton, PA)
- …Quality Assurance, Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge ... If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and building a… 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 ... and ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management .--The Associate Director , External Manufacturing Operations will also… more
- Tris Pharma (Monmouth Junction, NJ)
- …procurement strategies and operations, contract negotiations, supplier relationship management , procurement systems functionality/workflows and assurance of ... in our Monmouth Junction, NJ facility for an experienced, hands-on SR. Director / Director , Procurement. Title and salary commensurate with experience. The … more
- Merck & Co. (San Francisco, CA)
- Job Description Position Description: Associate Director , DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) ... with the DSCS Digital Leadership Team to drive the execution and management of DSCS Digital initiatives.Development Sciences and Clinical Supply (DSCS) enables Drug… 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 ... acceptability and identification of potential risks.Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for… more
- Insmed Incorporated (San Diego, CA)
- …part of a team is crucial. Experience with laboratory data management systems (LIMS) and statistical software is preferred.Salary Range139000-195200Compensation ... process development support testing function within analytical development. Will develop systems and processes to facilitate rapid, high throughput testing. As the… more
- Lundbeck (TX)
- …brain disease. Join us on our journey of discovery! POSITION SUMMARY: The Director , Chemical Biology leads a world-class team researching new understandings of the ... behavior of biological systems and their interactions with small molecules, in order...to early milestones Leads the design and synthesis of high- quality small molecule tools and early hits Working closely… more
- Insmed Incorporated (Los Angeles, CA)
- …Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director Medical Science Liaison will develop and maintain professional ... and education to health care customers within managed markets/healthcare/payor systems , in addition to other unique healthcare influencers.Full support and… 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 ... plans.Ensure that the operation is in compliance with all aspects of Repligen's IS09001 Quality Management Responsible for ensuring that work area is clean and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with strategic alignment Effective in fast-paced environments with a focus on quality and documentation Skilled in change management and guiding teams ... cutting-edge AI/GenAI technologies and developing AI/GenAI products to deliver high quality insights with speed and efficiency Promotes a culture of creativity… more
- Merck & Co. (Rahway, NJ)
- …Capital Projects, Collective Bargaining, Compliance Assurance, Computerized Maintenance Management Systems (CMMS), Digital Transformation, Driving Continuous ... Job DescriptionAssociate Director HVAC : The HVAC Associate Director...Emerging Technologies, Energy Efficiency, Equipment Maintenance, GMP Compliance, HVAC Systems , Key Performance Indicators (KPI), Maintenance Management ,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …4+ years of proven leadership experience managing technical and validation teams, preferably at Director or Senior Management level - Required 7+ years of strong ... 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)
- ….This position is responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role is responsible for assisting the document ... 1-2 years' experience in Document Control in an ISO 9001 certified Quality Management System or equivalentStrong knowledge of Microsoft Office, including… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** The Associate Director , Digital Quality Management Systems (QMS) Operations and User Experience, is responsible for ensuring the ... and training programs to enhance user adoption and competency with digital quality systems . + Conduct user engagement initiatives, including webinars, workshops,… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- Description: The Director , Quality Management System is responsible for standardization and proactive compliance of Amneal's QMS with the worldwide drug, ... This role is responsible for compliance monitoring, compliance risk identification, quality plan for new requirements, site inspection readiness, and regulatory… more
- Mohawk Valley Health System (Utica, NY)
- …Department: QUALITY IMPROVEMENT Job Summary The Senior Director of Quality Management Systems and Regulatory Affairs is responsible for establishing ... regulatory operations throughout the organization. The Senior Director of Quality Management Systems & Regulatory Affairs is accountable for developing,… more
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