- Merck & Co. (Rahway, NJ)
- …and global functions such as infrastructure, engineering, system security, risk management , etc.Education Requirement:-Bachelor's degree in automation, ... analyzing and solving incidents, problems, identifying root causes and performing crisis management roles.Lead efforts to map and design operational service… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Franchise project plans, project timelines, high quality risk management plans, and communication plans, as needed. Operational Excellence SupportCollaborate ... Management & Operational Excellence provides strategic planning and operational management oversight of GOMA projects, activities, and budgets.The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …materials and knowledge articles; maintain documentation for the Change Management process . Guide and support the operational team with operational ... and accountable for managing and maintaining the IT Change Management process . You should be familiar with...service management , with a focus on Change Management required- Good specific operational knowledge on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming standards and ... study data protection, operational metrics, and clinical trial quality and risk management reporting requirements. Oversees the execution of external data --… more
- Merck & Co. (Rahway, NJ)
- …in Data Integration/Analytics tools, Cloud Computing/Technologies (AWS), and Business Process Management (BPM).Experience with HCM Cloud Connectors (CCW, ... Compensation and Benefits and other related solutions.Lead end-to-end project management for HR Compensation and Benefits initiatives, including planning,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …area. May represent Clinical Operations on the DS/CRO Joint Operating Committee. Work with Process Excellence and Risk Management to ensure oversight plans ... rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and...Daiichi Sankyo's quality measures. Leads the creation of the Risk Identification and Management Log (RIM Log)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … performance, identifying trends, and implementing corrective actions when necessary Risk Management : Assessing and mitigating risks associated with operations, ... team members to develop, plan and execute on the opportunity or mitigation Process Improvement: Identifying areas for improvement in operational processes and… more
- Tris Pharma (Monmouth Junction, NJ)
- …implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and resolution) of ... New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports,… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... drawingsProcess development and technology transfer experience including the use of risk assessment and process capability (Ppk) tools.Candidate should have… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …position may require the Sr. CSM to take the role of both operational strategy and study execution. Responsibilities:Study Management & Leadership:Has primary ... written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …feasibility, and implementation of study objectives. Implement and use efficient project management tools, eg, Communication Plan and Risk Based Quality ... Associate Director role will be responsible for all aspects of clinical trial management and oversight of trial teams. Relationships This position reports to the… more
- Genmab (Plainsboro, NJ)
- …will have the ability to exercise their skills and knowledge on process management & improvement, strategic & risk management planning, change ... supply challenges to maintain trial timelines and align efforts across teams. Process Management and ImprovementOptimize processes and implement digital solutions… more
- Merck & Co. (Durham, NC)
- …interpersonal, leadership , and collaboration skills responsible for s upporting Operational Readiness projects to support biological processes for a new ... requirements ; - - Applies supervisory skills to improve efficiency and accomplish operational objectives within own unit ; - - Identifies and resolves standard… more
- Merck & Co. (Durham, NC)
- …and operational problems through collaboration with peers.Applies appropriate risk management while adhering to cGMP requirements.Makes decisions guided ... management of all activities required to successfully support Process Performance Qualification (PPQ) and routine manufacturing to include the following:Ability… more
- Merck & Co. (Durham, NC)
- …or drug product. GMP experience with qualification of equipment. Experience with Quality Risk Management . Project Management experience in a highly regulated ... of process simulation batch records. Perform Quality retain sample management activities, if applicable. Lead Shopfloor audits to identify and address… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …CPP/CQAs are defined and understood by engineering and incorporated into design and control functions. Risk Management - assures risk management decisions ... analysis in manufacturing design, then goes into addressing risk in process validations, and continues with...team exercises to evaluate and identify potential failures modes, risk , and opportunities related to operational processes,… 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, ... team collaboration, training and development, employee engagement, and recognition Change Management : Identifying areas for improvement in operational processes… more
- Merck & Co. (Durham, NC)
- …self-directed strong skill sets in planning / scheduling, and time management .Experience with Quality Risk Management .Experience with Deviation ... QA proceed in compliance with cGMP, regulations, and our Company's Quality Management System focusing on batch record review, process /aseptic observations,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …linking data, and maintaining applicable procedures Core roles include communication, compliance, risk management , and use of current technology The role ... This position is responsible for the ownership of the Engineering Data Management System (EDMS) while collaborating with the Engineering team to provide necessary… more
- Merck & Co. (Durham, NC)
- …or drug product. GMP experience with qualification of equipment. Experience with Quality Risk Management . Project Management experience in a highly regulated ... our current maximum manufacturing capabilities. Once this new facility is fully operational , we will triple our current manufacturing capacity, which is expected to… more
