- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …achievement of Company and/or departmental expectations and goals as identified by senior management .ResponsibilitiesActs 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.Leads… more
- Ankura (New York, NY)
- …Support project teams on advisory matters relating to corporate and healthcare compliance , including risk assessments, compliance program effectiveness ... on driving value to Life Sciences clients and external counsel through compliance , disputes, investigations and advisory services. The position has tremendous growth… more
