- Insmed Incorporated (San Diego, CA)
- …plansIndependently lead the central messaging, preparation, and submission of high quality , regulatory complaint regulatory dossiersDirect hands-on ... with Regulatory Operations, and/or third-party service providers, ensure high quality , on-time submission activities related to regulatory file maintenance… more
- Merck & Co. (Rahway, NJ)
- …approvals and systems are in place to maintain the scientific, technical and regulatory quality of all CMC submissions, correspondence, and interactions with ... our company. They will lead a team of CMC professionals, ensuring rigorous CMC regulatory strategy and delivery of high- quality submissions for products that may… more
- Insmed Incorporated (San Diego, CA)
- …Director of Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality ... (Essential Role Responsibilities):Establish and maintain a risk-based and scientific-based quality system to support GCP.Oversee regulatory agency inspections… more
- Repligen (Waltham, MA)
- …manage Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate cross-functional teams to assess and mitigate ... supporting root cause investigations, and ensuring Repligen's supplier network meets regulatory and quality standards. This role is based in Waltham, MA, and… more
- Merck & Co. (Philadelphia, PA)
- …activities related to planning, execution, and management of delivery of high quality and timely regulatory submissions.The responsibilities of the incumbent may ... Management Process, Manufacturing Quality Control, Organizational Performance Management, Quality Management, Regulatory Affairs Compliance, Regulatory … more
- Merck & Co. (Rahway, NJ)
- …advisor for all teams working on Autoinjectors, fostering collaboration among engineering, quality assurance, regulatory , and manufacturing teams across the CMC ... medical device engineering, particularly in the design, manufacturing, and regulatory aspects of Autoinjectors and combination products.Primary Responsibilities:Technical Strategic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Management to ensure safety information is processed according to corporate timelines, quality and regulatory requirements Leads the safety follow-up process ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Merck & Co. (Rahway, NJ)
- …Decision Making, Drug Development, Good Clinical Practice (GCP), Nursing, Patient Education, Quality Management, Quality Standards, Regulatory Compliance, ... Maintain training materials in compliance with applicable SOPs, policies, and regulatory requirements. - Defines and contributes to the development of training… more
- BioAgilytix (Durham, NC)
- …tools that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a ... at diagnosing data challenges and designing innovative solutions to improve data quality , integration, and regulatory adherence.Capable of growing with the role… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management related topics and establishes the oversight model for timely and quality delivery and regulatory compliance of outsourced activities.- Ensures ... to database release, data review and cleaning, database lock), to ensure data quality /integrity and regulatory compliance- Ensures that Data Management Plans are… more
- Merck & Co. (Rahway, NJ)
- …packaging & device development and technology teams, supply chain, operations, quality , analytical, regulatory , and project leaders. The successful candidate ... maintain strong relationships with internal stakeholders, including packaging commercialization, quality , analytical, regulatory , manufacturing, Device Development and… more
- Merck & Co. (Rahway, NJ)
- …manufacturing sites, device development and technology teams, supply chain, operations, quality , analytical, regulatory , and project leaders. The successful ... maintain strong relationships with internal stakeholders, including packaging commercialization, quality , analytical, regulatory , manufacturing, Device Development and… more
- Merck & Co. (Rahway, NJ)
- …with internal stakeholders, including supply chain, packaging commercialization, quality , analytical, regulatory , manufacturing, Device Development and ... substance and drug product container closure systems including mold qualification and regulatory compliance.- To act as master data stewards and support enterprise… more
- Genscript USA Inc. (Piscataway, NJ)
- …with cross-functional teams is essential to ensure supply continuity, compliance with quality and regulatory standards, and readiness for audit requirements. The ... and consumables used in production, ensuring alignment with cost objectives, quality standards, and regulatory requirements. Develop alternative vendors for… more
- Merck & Co. (Rahway, NJ)
- …and maintain strong relationships with internal stakeholders, including commercialization, quality , analytical, regulatory , manufacturing, and Supply Chain to ... and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make… more
- Merck & Co. (Rahway, NJ)
- …Drug Product/Oral Solid Dose (OSD) manufacturing & development experience.Familiarity with Quality , Regulatory , cGMP, Safety & Environmental Policies and ... development & production areas; execute periodic reviews, and support Quality Management System (QMS) activitiesQualificationsBachelor's Degree in Engineering or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …investigations and root cause analyses on any supply disruptions or material quality related issues.Support Quality , Regulatory and Financial audits.Provide ... team on implementing supplier performance metrics [e.g. Assurance of Supply, Quality , Service, Cost & Innovation] and develop dashboards/reports.Builds and maintains… more
- Merck & Co. (Rahway, NJ)
- …and maintain strong relationships with internal stakeholders, including commercialization, quality , analytical, regulatory , manufacturing, and Supply Chain to ... and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …investigations and root cause analyses on any supply disruptions or material quality related issues.Support Quality , Regulatory and Financial audits.Provide ... timely responses to business units' representative(s) and suppliers' inquiries.Assist with the development and implementation of standard operating procedures, work instructions and training materials.Support end to end supply chain activities and work… more
- AUROBINDO (Dayton, OH)
- …management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under ... operational problems and inefficiencies and recommend resolutions.Participate in any regulatory inspections from various organizations such as FDA, Environmental… more
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