- Genmab (Plainsboro, NJ)
- …policies; and (ii) the implementation and oversight of Genmab's third-party privacy risk compliance function. Successful candidates will have a deep ... and ongoing oversight of Genmab data processors in accordance with Genmab's risk management framework and data privacy and protection policies.Works closely… more
- 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
- 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 ... project proceed in compliance with cGMP, regulations, and our Company's Quality Management System. Provide QA shop floor support in the execution and review of… more
- Merck & Co. (Durham, NC)
- …Standards (QMS) and Site Standard Operating Procedures (SOPs) as part of operational compliance .- Experience with pharmaceutical equipment or utility systems. ... Experience with EM sampling Global Laboratory Information Management System (GLIMS), Experience participating in Quality Risk Assessments (QRAs) Experience with… 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)
- …Compensation and Benefits and other related solutions.Lead end-to-end project management for HR Compensation and Benefits initiatives, including planning, ... and work with multiple teams to develop and design solutions.Manage operational and project budgets.Identify and implement improvements to reduce costs.Build 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 ... Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management ...systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Operations on the DS/CRO Joint Operating Committee. Work with Process Excellence and Risk Management to ensure oversight plans are in place for all ... 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)
- …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
- 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 ... to ensure timebound progression of portfolio, initiatives for scientific & operational excellence, and other strategic goals that advance functional impact.The… 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
- Merck & Co. (Durham, NC)
- …self-directed strong skill sets in planning / scheduling, and time management .Experience with Quality Risk Management .Experience with Deviation ... in compliance with cGMP, regulations, and our Company's Quality Management System focusing on batch record review, process/aseptic observations, critical site… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Risk Evaluation and Mitigation Strategy (REMS) including the management and oversight of systems supporting these processes. It involves coordinating and ... the Department At Novo Nordisk, we're committed to building the best Ethics, Compliance & Privacy (ECP) team in the pharmaceutical industry. Operating at the highest… more
- Genmab (Plainsboro, NJ)
- …their skills and knowledge on process management & improvement, strategic & risk management planning, change management and stakeholder management . ... the team that is in the leading role in the planning of operational excellence, strategic planning, and innovation implementation for the Global Clinical Drug Supply… more
- Merck & Co. (Durham, NC)
- …interpersonal, leadership , and collaboration skills responsible for s upporting Operational Readiness projects to support biological processes for a new ... - Applies supervisory skills to improve efficiency and accomplish operational objectives within own unit ; - - Identifies...the efficiency and effectiveness of own unit ; - Compliance - Responsible for creating and sustaining a culture… 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 ... in compliance with cGMP, regulations, and our Company's Quality Management System. Supporting areas such as Design, Commissioning, Qualification and … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …completed in compliance and meets Novo Nordisk's business standards Risk Management : Assessing and mitigating risks associated with operations, implementing ... team collaboration, training and development, employee engagement, and recognition Change Management : Identifying areas for improvement in operational processes… more
- Merck & Co. (Durham, NC)
- …and operational problems through collaboration with peers.Applies appropriate risk management while adhering to cGMP requirements.Makes decisions guided ... Responsibilities:The Quality Senior Specialist will be responsible for comprehensive management of all activities required to successfully support Process… more
- Merck & Co. (Durham, NC)
- …area safety, compliance , production and financial goals are metSpare parts risk -based assessments and identification of new parts to replace obsolescent parts to ... with optimized product quality and manufacturing processes and regulatory compliance . GENERAL PROFILE Provides leadership and direction through individual… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …archiving, linking data, and maintaining applicable procedures Core roles include communication, compliance , risk management , and use of current technology ... This position is responsible for the ownership of the Engineering Data Management System (EDMS) while collaborating with the Engineering team to provide necessary… more
