- Merck & Co. (Rahway, NJ)
- …(include Requirements For Education, Experience And Skills)Job Description:The Associate Director Quality Assurance, Facilities, Validation & Automation will ... sterile processing and sterility assurance practices and guidelinesStrong experience with QRM ( Quality Risk Management)Strong working knowledge of SDLC, GAMP and… more
- Eisai, Inc (Nutley, NJ)
- …governance and management.Certified Information System Manager (CISM), Certified in Risk and Information Systems Control (CRISC), Certified Information ... JSOX compliance.Maintain accurate compliance documentation and advise control owners.Assess risk , evidence adequacy, and remediate findings.Evaluate new system … 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)
- …company policies.The Associate Director also ensures that effective and robust Quality systems are followed to comply with required regulations, policies and ... Job DescriptionThe Associate Director , ESQL is responsible for all activities at...subject matter expert for EQA and Division in specific Quality systems , technology platforms, regulatory expectations and/or… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director , PMO People & Process LeadGlobal Project and Alliance Management (GPAM) sits in the Research & Development organization at our ... their parts of the Research & Development division.The Associate Director , PMO People & Process Lead, is a unique...of how our clients navigate business processes and enabling systems to deliver their job responsibilities. In this role,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …proposals for formal presentation to senior management.Generates and maintains high quality risk management and communication plans. Independently identifies ... meeting management, development plan/timeline management, scope management, stakeholder management, risk /issue management, finance and resource management, and conflict resolution.… more
- Eisai, Inc (Nutley, NJ)
- …we want to hear from you. Job Summary: As the Americas Infrastructure Director , your role involves collaborating with other Eisai regions and global Enterprise ... leadership to managed services vendors to drive performance improvement, quality , and cost optimization.Drives a culture of continuous improvement that… more
- Merck & Co. (Millsboro, DE)
- …implementing and providing operational support of SCADA/DCS, historian and/or MES systems (eg DeltaV, AVEVA System Platform, Werum, Ignition, etc.)Understanding ... Job DescriptionPosition Description: Associate Director - Site Digital Technology Lead The Site...other global regulatory requirements that impact IT and OT systems in Manufacturing, Quality and Supply ChainKnowledge… 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
- 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
- Insmed Incorporated (Bridgewater, NJ)
- …include, but not necessarily be limited to, the following:Facilitate and maintain a risk -based and scientific-based quality system to support Good ... writing audit reports as well as reviewing and tracking CAPAs.Broad knowledge of risk -based quality systems approaches consistent with post-marketing Good… more
- Merck & Co. (Rahway, NJ)
- …Training, and SOPs for all GxP automation systems .-Integration of control systems with MES, Quality , and Batch Reporting applications.Understand and adhere ... on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the BDC Pilot… more
- Merck & Co. (Rahway, NJ)
- …IT financial planning and forecasting processes and manage updates to systems of record.Ensuring data consistency and accurate mapping across various trackers ... and systems of record - ie product model mapping for...The incumbent will be responsible for ensuring the consistency, quality , reliability, efficiency of the information used to make… 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 ... Management will provide strategic direction and leadership for the investigations management system . Working closely with the Quality Senior Manager, this… more
- Merck & Co. (Rahway, NJ)
- …modalities. We are interdependent across our functional areas, Discovery, our Manufacturing Division Quality , and BARDS, to name a few, and with our partners in ... intra- and inter-divisional communications.-Optimize program execution inclusive of Scope, Quality , Timeline and Budget.-Partner with our Company IT leadership to… 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)
- …and is accountable to set strategy for the delivery of high quality and compliant statistical analysis and reporting.Direct the activities of programmers whose ... ensuring that project plans are executed efficiently with timely and high- quality deliverables.Manage the analysis and reporting deliverables of Functional Sourcing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the end-to-end delivery of ... data collection services on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse external providers for clinical… more
- Merck & Co. (Rahway, NJ)
- …execution of capital and non-capital improvement projects, and the automation system assets spanning production, utility systems and associated infrastructure.- ... responsibility. The Specialist - Manufacturing Automation position will report to the Director , Engineering, Automation Lead position and will be a member of the… more
- Merck & Co. (Rahway, NJ)
- …global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, ... Job DescriptionDevice Development Principal Scientist - Device Development Lead ( Director Equivalent) Our company's Device Development (DD) Team designs, develops,… more
