- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position This role directs and operationalizes NNI's Ethics & Compliance (E&C) risk management program by leading and managing four ... Advanced degree preferred Minimum of twelve (12) years of combined experience in risk management , ethics & compliance , or legal roles in the pharmaceutical… more
- Merck & Co. (Rahway, NJ)
- …activities such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead and/or quality subject ... Job Description Job Description: The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and approval… more
- Merck & Co. (Rahway, NJ)
- …and global functions such as infrastructure, engineering, system security, risk management , etc.Education Requirement:-Bachelor's degree in automation, ... RaDS IT Research Infrastructure Product Line (RIPL) engineering team is seeking a Senior Specialist - Research Automation OT Infrastructure. This position will be a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key ... written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally… more
- Twist BioScience (South San Francisco, CA)
- …assessing control risks, driving and tracking SOX remediation initiatives, and communicating compliance status to senior management and external auditors. ... The Director of Internal Controls and Financial SOX Compliance is a senior -level position responsible,...to business technology integrationsPartner with control owners to perform management assessment of risk over internal controls… more
- Genmab (Plainsboro, NJ)
- …an innovative and growing organization? At Genmab, we're seeking a Senior Director, Strategic Planning & Effectiveness to drive cross-functional communication, ... cross-functional and global franchise leadership meetings, escalating critical issues to senior leadership.Collaborate with the SVP to manage US Oncology Leadership… more
- Novo Nordisk Inc. (Durham, NC)
- … Operate within compliance with a Quality Mindset that focuses on risk management & mitigation Implement effective Change Management Support Corporate, ... of application requirements through relationship building & effective stakeholder management Gather information about stakeholders' needs/process gaps & develop/implement… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of Works (SOWs). The AD will be responsible for providing supplier management support and oversight to the North America CMR Organization. Additional ... budgeting guidance. Collaborating with cross-functional teams to ensure contractual compliance and driving continuous improvement. Works closely with suppliers to… more
- Merck & Co. (Rahway, NJ)
- …with internal teams across the organization, including legal, regulatory affairs and senior management to develop strategies and execute plans.This role involves ... Job DescriptionThe Director, Issues Management and Crisis Mitigation is responsible for driving...risks and threats to the business and reputation, conducting risk assessments and scenario plans, developing issues preparedness 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …globally and with external parties as required.Champions 'Quality by Design' and Quality Risk Management approaches to quality management within Daiichi ... other key drivers of enhanced quality.Aligns with the RBQM Risk Management Lead on critical-to-quality factors and...activities for Daiichi Sankyo Portfolio of Studies: Serve as senior level technical RBQM SME and oversee and mentor… 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 ... as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders in development.The… 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 ... ensure compliance with Daiichi Sankyo's quality measures. Leads the creation of the Risk Identification and Management Log (RIM Log) and other risk … more
- Merck & Co. (Rahway, NJ)
- …manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical ... engineering design, engineering analysis and testing, medical device design controls, risk management , test method/fixture development, design verification and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …investments, companion diagnostic, academic research organization, and acquisition deals. Advises senior management on legal and regulatory issues, leads complex ... or processes.Monitors current developments in assigned key legal areas and provides Senior Management and other business leaders with updates regarding same… 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 ... Job DescriptionPosition Description: Senior Specialist, Quality Assurance Our Company will construct...compliance with cGMP, regulations, and our Company's Quality Management System. Supporting areas such as Design, Commissioning, Qualification… more
- Merck & Co. (Durham, NC)
- …of technical and operational problems through collaboration with peers.Applies appropriate risk management while adhering to cGMP requirements.Makes decisions ... qualification/validation activities supporting the vaccine expansion facility.Primary Responsibilities:The Quality Senior Specialist will be responsible for comprehensive management… more
- Merck & Co. (Rahway, NJ)
- …its customers, and shareholders. The scope of this group includes strategic program management , enterprise strategic planning, risk management , as well as ... consensus and influencing decision-making.Strong communication skills to effectively engage with senior management and across all levels of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …helping to develop and deliver processes, training, procurement technology and knowledge management tools. Closely partners with senior Business stakeholders to ... all Strategic Sourcing efforts through to final contract, including project management , supply analysis, supplier identification, risk mitigation, sourcing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …achievement of Company and/or departmental expectations and goals as identified by senior management .Responsibilities- Acts as a brand attorney and lead legal ... departments. Monitors current developments in several key legal areas and provides Senior Management and other business leaders with updates regarding same.-… more
