- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …at program level and along the GvP modules in support of a proactive quality risk management process.Interact with the audit and compliance function ... identified through audits, inspections, internal meetings, remediations and risk management in close collaboration with the organization's quality … more
- Merck & Co. (North Wales, PA)
- …and Combination Product (MDCP) Quality Assurance Operations team, the Associate Director Quality Engineering & Quality Assurance is responsible for ... of a combination product.Review and approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development,… more
- Merck & Co. (Rahway, NJ)
- …with delivering effective CAPA management solutions.Experience with risk management tools and processes within the clinical quality framework. Skills ... quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities. The position… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for formal presentation to senior management .Generates and maintains high quality risk management and communication plans. Independently identifies ... performance against the budget.Maintains global integrated project plans, project timelines, risk management , plans and communication plans. Supports scenario… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Director US Oncology Policy position is a high exposure and high impact commercial role accountable for executing key policy initiatives ... our ability to anticipate changes in the market, prepare accordingly, and mitigate risk so we can continue ensuring appropriate patient access to our Company's… more
- Merck & Co. (Rahway, NJ)
- …fast-paced job that provides a high degree of technical and project management responsibility. The Associate Director - Process/Facility Engineering position ... will report to the Director , Engineering and will be a member of the...compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific… more
- Merck & Co. (Rahway, NJ)
- …country program rollout with cross divisional and market stakeholdersStrategic thinking, risk management , and roadmap planning for data product evolutionEnsure ... Job DescriptionPosition Description: Associate Director Data Product Management Job Description We are seeking a strong, highly energetic and collaborative… more
- Merck & Co. (Millsboro, DE)
- …DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/ ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...all federal and state regulatory requirements for animal welfare, management of controlled substances, quality control testing… more
- Eisai, Inc (Nutley, NJ)
- …stakeholders from EIT and leaders across regions in Compliance, Ethics, Risk Management , Legal, Data Privacy, and Information Protection.Security ... Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the...including at least 5 years of enterprise-level governance and management .Certified Information System Manager (CISM), Certified in Risk… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit ... accelerate process and product development and manufacturing and ensure safety and quality of our products. -The successful candidate will be accountable for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.- Define and implement ... for overall product safety strategy or specific areas of safety surveillance and risk management , and provide safety leadership including but not limited to… more
- Merck & Co. (Rahway, NJ)
- …or manufacturing environment. Experience supporting compliance investigations and change management . Experience working with Quality systems. Experience working ... provides a high degree of technical, project, and people management responsibility. - This SSO Facility Lead role within...pilot plant. The Facility Lead position reports to the Director of Operations/Head of SSO Pilot Plant and the… more
- Merck & Co. (Durham, NC)
- …Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain Capital project management experience Risk Management experience Experience ... work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work...substance manufacturing facility. As a direct report to the Director of Operations, the Associate Director will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Co-Lead Deviation Investigations: Collaborate closely with the Quality Associate Director to co-lead the deviation investigations management system. Ensure ... Technical Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide… more
- Merck & Co. (Rahway, NJ)
- …across the planning and control ecosystem.Under the broad guidance of the Executive Director , Head of our division's GPAM Project Management Office, the core ... Job DescriptionAssociate Director , PMO People & Process LeadGlobal Project and Alliance Management (GPAM) sits in the Research & Development organization at our… more
- Eisai, Inc (Nutley, NJ)
- …standards.Experience in implementing and maintaining robust cybersecurity practices, including risk management , access controls, network security, and ... 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)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study ... planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the...of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …conduct is completed in compliance and meets Novo Nordisk's business standards Risk management : Assessing and mitigating risks associated with operations, ... a collaborative work culture, including direct partnership with the Operations Director (s) Stakeholder management : Build strong internal and external… more
- Merck & Co. (Rahway, NJ)
- …and knowledge transfer from research to production sitesEnsure knowledge management and process monitoring activities to ensure appropriate process ... talent development.Ensure adherence to all applicable regulations, guidelines, and quality standards, including cGMP, FDA, and other regulatory requirements.Safety… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality Assurance, Medical ... and the business users to define user information needs.Provide informatics project management , SDLC Quality Model expertise, and computer system validation… more
