- Eisai, Inc (Nutley, NJ)
- …we want to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to ... controls.Monitor IT compliance risks to an acceptable level.Manage IT compliance issue resolution.Report compliance risk levels to key… more
- Merck & Co. (Durham, NC)
- …support to assigned areas of focus including but not limited to quality risk management, strategy development, development/revision of standard operating ... priorities and complex problems in a fast-paced environment.Aseptic manufacturing and GMP quality experience.Experience with Quality Risk Management and… more
- Merck & Co. (Rahway, NJ)
- …to all applicable regulatory requirements, regulatory filings and company policies.The Associate Director also ensures that effective and robust Quality systems ... Job DescriptionThe Associate Director , ESQL is responsible for all activities at...all applicable policies and procedures of the Company and compliance with all governing regulations.Responsibility for Quality … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the ... Technical Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide… more
- Merck & Co. (Durham, NC)
- …make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant ... to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. Our...substance manufacturing facility. As a direct report to the Director of Operations, the Associate Director will… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionPosition Description: Associate Director - Site Digital Technology Lead The Site Digital Technology Lead is the representative for Global Animal ... accountable for the full technology stack across all aspects of Operations, Supply, Quality and Business support at the Millsboro site. The Site Digital Technology… more
- Eisai, Inc (Nutley, NJ)
- …standards.Experience in implementing and maintaining robust cybersecurity practices, including risk management, access controls, network security, and compliance ... we want to hear from you. Job Summary: As the Americas Infrastructure Director , your role involves collaborating with other Eisai regions and global Enterprise… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the oversight, performance and management of CROs and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of ... Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and make the appropriate changes to ensure trial conduct is completed in compliance and meets Novo Nordisk's business standards Risk management: Assessing and ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(from business understanding, over hands-on development to dissemination), to ensure high quality deliverables are on time and within budget. The position holder ... skills in continuous improvement, project management, change management and risk management.Responsibilities Project level AI/ML activities - Responsible, with… more
- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of ... Pharmacovigilance QA serves as a strategic partner managing quality and regulatory compliance related to Good...necessarily be limited to, the following:Facilitate and maintain a risk -based and scientific-based quality system to support… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance , the Director , ... of compliance requirements, work with critical suppliers to ensure quality , consistent supply.Review and monitor all lab processes to ensure they follow… more
- Merck & Co. (Rahway, NJ)
- …forecastStrong partnership and alignment with EIT Finance and IT PMOEnsure compliance with IT financial controls and standardsQualifications, Skills & Experience: ... and renewals.- The incumbent will be responsible for ensuring the consistency, quality , reliability, efficiency of the information used to make financial decisions… more
- Merck & Co. (Rahway, NJ)
- …on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the BDC Pilot ... SOPs for all GxP automation systems.-Integration of control systems with MES, Quality , and Batch Reporting applications.Understand and adhere to CFR, GMP, and data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …manage, with limited direction, Biostatistics study activities assigned and ensure high quality deliverables are on time and within budget. The position may also ... require proven skills in continuous improvement, project management, change management, and risk management. The position will act as main statistical contact for… more
- Tris Pharma (Monmouth Junction, NJ)
- …success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety. The Director , Drug Safety is responsible for planning, ... safety reports, periodic safety reports, signal detection activities and risk management planning. The incumbent works cross-functionally with counterparts/teams in… more
- Merck & Co. (Rahway, NJ)
- …Sourcing Partners.Ensure appropriate and consistent application of SOPs, standards and quality and compliance measures.Engage with cross functional stakeholders ... statistical programming deliverables using global and TA standards and according to quality , compliance and timeliness requirements; expertise in SAS and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables on time and within budget to support drug development ... skills in continuous improvement, project management, change management, and risk management. ResponsibilitiesLeadership, Direction, and Strategy:Provides data management (DM)… more
- Catalent (St. Petersburg, FL)
- …accordance with templates and liaise with site and Suppliers to finalize to allow Supplier Quality Director approval Act as a liaison between suppliers and the ... committed to a Patient First culture through excellence in quality and compliance , and to the safety...Pre-Audit Preparation activities with an understanding of requesting sites risk assessment to ensure alignment to Global Standards Ensure… more
- Merck & Co. (Rahway, NJ)
- …and work. Manage local conflicts between resource and work.Ensures CTC compliance to corporate policies, procedures and quality standards.Skills:Demonstrates ... for execution and oversight of local operational clinical trial activities-in compliance with ICH/GCP and country regulations, company policies and procedures… more
