- Merck & Co. (Rahway, NJ)
- …role is a great career move for you! Position Summary As the Communications and Change Management Lead for the Business of IT program, you will play a critical ... ensuring effective collaboration and performance across team members. Principal Responsibilities Change Management Lead Assess the impact of Business of IT… more
- Merck & Co. (Rahway, NJ)
- …devices and combination products globally.- Experience in design controls, device risk management , medical device, complex combination product kits, prefilled ... picture, and how activities link to our Company strategy and business goals- Utilize device risk management tools to build device or combination product risk … more
- Merck & Co. (Rahway, NJ)
- … goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release, Change Control).- ... for establishing a strong business partnership and ensuring excellence in Compliance , Supply, Continuous Improvement, and Cost Management .--The Associate… more
- Merck & Co. (Rahway, NJ)
- …and inspire accountabilityEthical, resilient, and committed to excellenceSkilled in risk management , team facilitation, and strategic planningExperience in ... Reporting directly to the Biologics Drug Substance Commercialization Leader, you will lead the Cell Banking working groups and drive innovation in biologics DS… more
- Merck & Co. (Rahway, NJ)
- …Ethical, resilient, and committed to scientific and operational excellence Skilled in risk management , team facilitation, and strategic planning Experience in ... Job Description Lead the Future of Biologics Drug Substance Commercialization!...analysis, and documentation of cell culture process commercialization Drive risk assessments, control strategies, comparability reports, PPQ, and regulatory… more
- Merck & Co. (Rahway, NJ)
- …Development Sciences (RaDS) value team in R&D IT brings together product management , engineering, and data science expertise. We enable data, technology and services ... the RaDS Product organization. The position will report to the- Lead of the Disease Biology and PharmTox Product Line....experience researchers, engineers, and data scientists to assess value risk , usability risk , feasibility risk … more
- Merck & Co. (Rahway, NJ)
- …both performance and talent management activitiesProven leadership and project management skills to lead cross functional teams, drive initiatives and ... with expertise in cell culture development & commercialization to lead a team of approximately 3-5 scientists, who ...accurate information and status updates to project sponsors and management .Manage and mentor a team of scientists specializing in… more
- Merck & Co. (Rahway, NJ)
- …, Project Portfolio Management (PPM), Publications Management , Regulatory Compliance , Risk Management , Sourcing and Procurement, Strategic Planning ... internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.-...program(s) (ie Bulk Drug Product).--Oversees all bulk drug supply management and ensures proper allocation of drug product as… more
- Merck & Co. (Rahway, NJ)
- …timely and accurate information and status updates to project sponsors and management .Champion compliance and safety; promote a culture of diversity, inclusion, ... cell bank process performance across programs, support timeline creation and management of work packages within project teams. Monitor and project resource… more
- Merck & Co. (Rahway, NJ)
- …programs.Technical scope:Direct projects focusing on cell bank process risk assessments, documentation, process characterization, technology transfer and ... and sustain technical standardization of best practices across the network. Lead assignment execution against accelerated timelines, in a right-first-time manner,… more
- Merck & Co. (Rahway, NJ)
- …Teamwork, Decision Making, Drug Development, External Manufacturing, GMP Compliance , Innovation, Management Process, Manufacturing Scale-Up, Process ... to apply each.- Leverages scientific data to make disciplined risk -based decisions and shown to be capable of discerning...others in an impactful manner with proven ability to lead complex discussions, influence stakeholders, and drive outcomes in… more
- Merck & Co. (Rahway, NJ)
- …talent Development.-The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including ... The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering… more
- Merck & Co. (Rahway, NJ)
- …challenges across projects and functional teams, in a fast-paced, multidisciplinary environment. Lead the development of robust and scalable upstream processes for ... the functional area; guide career development; build strong, collaborative teams.Champion compliance and safety while promoting a culture of diversity, equity, and… more
- Merck & Co. (Rahway, NJ)
- …to work strategically and in a detail-oriented framework with all levels of management .Must have strong understanding of product management systems and tools, ... to apply each.- Leverages scientific data to make disciplined risk -based decisions and shown to be capable of discerning...others in an impactful manner with proven ability to lead complex discussions, influence stakeholders, and drive outcomes in… 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 ... preferred, candidates from Upper Gwynedd, Pennsylvania, will be considered.Primary Responsibilities: Lead and support the development of enterprise critical commercial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Collaboration:Facilitate effective communication and collaboration with internal stakeholders, including IT and Compliance Risk Management as well as Global ... culture of compliance and accountability in data management practices. The position also involves risk -based...PV QA) and is a member of the leadership team. Lead an enterprise cross-functional QA team to deliver state-of-the-art… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Finally, this position has advanced skills in continuous improvement, project management , change management , and risk managementResponsibilities: Leadership, ... Data Management globally and ensures execution of the global data management strategy across regions and across studies/programs. Lead DM resource model… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …proactively represented at program level and support proactive quality risk management process.Interact with the audit and compliance function for the ... alignment with the business strategy Lead the DSG inspection management activities by ensuring continued submission, compliance and inspection preparedness… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in a fast-paced environment, continuous improvement, project management , change management , and risk management . Responsibilities: Leadership, Direction, ... levels and from different disciplines and cultures. This position requires demonstrated line management experience and the ability to manage/ lead people and a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requires skills in working in a fast-paced environment, continuous improvement, change management , and risk management . Experience working and managing ... rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM ( Risk Based Quality Monitoring) sets the vision and strategy for the RBQM function… more