- Formation Bio (New York, NY)
- …change management , and vendor oversight. The Sr. Director ensures compliance with cGMP standards, oversees QA activities at CDMOs, performs critical ... and implement corrective and preventive actions (CAPA effectively. Proficiency in quality management tools and methodologies (eg, risk assessment, root cause… more
- Merck & Co. (Rahway, NJ)
- …areas of the enterprise. Areas included, but not limited to are, overall supplier management , compliance , risk management , diversity spend, and ... as directed.-In addition to providing primary expertise in Capital planning, engagement management and performance improvement the senior specialist will provide… more
- Genmab (Plainsboro, NJ)
- …and CROs to oversee sponsor oversight visits and ensure quality and compliance across all activities.Site Selection and Management Collaborate with the ... and completeness of the eTMF, supporting inspection readiness and regulatory compliance .Maintain relevant sections in Clinical Trial Management Systems and… 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
- Merck & Co. (Rahway, NJ)
- …stakeholders at all levels, ensuring their commitment to the technical transfer vision. Risk Management , Compliance Oversight & Decision Making:Lead the ... rigorous technical support processes to support manufacturing sites, proactive risk management , performance monitoring, and continuous improvement.-Experience… more
- Merck & Co. (Rahway, NJ)
- …devices and combination products globally.- Experience in design controls, device risk management , medical device, complex combination product kits, prefilled ... Job Description Summary, Focus and Purpose The Senior Engineer in Device Technology is a key...to our Company strategy and business goals- Utilize device risk management tools to build device or… 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)
- …effectively communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. Strong ... company marketed products . - Analyzes and anticipates project risk s as they relate to clinical supply chain...develops mitigation strategies for review with clinical partners and senior leaders.- - Works directly in the SAP system… more
- Merck & Co. (Rahway, NJ)
- …Associate Director, Safety Programs CoE.- This individual will be responsible for the management of a portfolio of corporate safety programs that may include High ... Risk Work, Fire & Life Safety and other similar...manage company's safety standards and technical guidelines to ensure compliance and reduction in workplace safety risks.Lead global continuous… more
- Merck & Co. (Rahway, NJ)
- …is focused on delivering exceptional performance in value creation, supplier management , and risk mitigation through strategic sourcing initiatives for ... & Performance Management (SD&PM) to ensure effective management and reporting of initiatives to senior ...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Tris Pharma (Monmouth Junction, NJ)
- … Leadership team including insights on financial performance, capital allocation, and risk management ; Directs cost monitoring and reporting activities; Drives ... In depth knowledge of corporate financial law, compliant financial reporting and risk management practices Excellent knowledge of data analysis and forecasting… more
- Merck & Co. (Rahway, NJ)
- …SAP capabilities with business strategies.Build relationships with business units, senior management , and external partners.Communicate SAP strategy, updates, ... RISE.Align SAP initiatives with business objectives in collaboration with senior leadership.Develop and implement an SAP enhancement roadmap for efficiency.Influence… more
- Merck & Co. (Rahway, NJ)
- …product development, such as manufacturing process development and validation, design control, risk management , material and molding, design validation to create ... with design verification, including but not limited to, design controls, risk management , materials & molding, process development and validation,… more
- Merck & Co. (Rahway, NJ)
- …effectively communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. Strong ... program(s) ( ie Bulk Drug Product).- - Oversees all bulk drug supply management and ensures proper allocation of drug product as needed across studies within… 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 ... verbal and written skills; ability to speak effectively with senior management and across all levels of...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- …supervision. The role will also be responsible for proactive resourcing planning, risk assessment strategies, and budget management as necessary.The Director, ... and will be directly responsible for a team of approximately 20 senior and associate-level scientists. The position is accountable for delivering NMR methodologies… more
- Merck & Co. (Rahway, NJ)
- …communicate with stakeholders at various levels, including cross-functional teams, senior management and external vendors. Strong negotiation, influencing, ... .- We deliver critical building and site services , including facility management , emergency response, utilities (including electricity and water), and real estate… 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 ... and site staff, Health Systems, Contract Research Organizations and Site Management Organizations etc.) Establish and manage senior level relationships… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …new ideas, solutions, methods or opportunities; foster innovation through appropriate risk -taking and experimentation to ensure that the Medical Promotional Review ... product labeling committees and other department projects/initiatives Demonstrates the people management skills needed to lead direct reports and working teams;… more
- Genmab (Plainsboro, NJ)
- …Prescribing Information depending on the role for the assigned product Consult with senior management to develop and communicate regulatory strategies and advice ... Profile). For approved products, ensure that regulatory strategies throughout life-cycle management are in place and implemented including label improvement, health… more
