- Merck & Co. (Upper Gwynedd, PA)
- …Organizational Change Management , Organizational Changes, Personal Initiative, Project Management , Readiness Assessments, Risk Management , Risk ... Framework Lead Establish / reinforce framework and approach to change management for the organizationLeverage technology innovations to upskill and support… more
- Aequor (Thousand Oaks, CA)
- …Deep understanding of Risk Based approaches and its impact with Data Management /Site monitoring operationally - consider the role of both Data Management and ... knowledge of Pinnacle 21, Centralized Statistical Monitoring, Quality by Design, Risk -based Quality Management etc. Determine key performance indicators (KPIs)… more
- Formation Bio (New York, NY)
- …propensity and eagerness to incorporate AI into their work, leveraging technology to enhance program management efficiency and effectiveness.Responsibilities ... trial operations. About You You're excited about the intersection of AI and program management and eager to explore how technology can streamline and scale… 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 ... space, including process flow diagrams & engineering drawingsProcess development and technology transfer experience including the use of risk assessment… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Finally, this position has advanced skills in continuous improvement, project management , change management , and risk managementResponsibilities: Leadership, ... trials and submissions work.Proactively identifies and manages risks for the data management function and supports functional risk identification/ management … more
- Merck & Co. (Durham, NC)
- …Personal Initiative, Process Innovation, Process Optimization, Professional Integrity, Project Management , Regulatory Inspections, Risk Control Assessment, Root ... over the last several years; currently Durham employs 1,000+ people. Durham's Technology Transfer Specialist will be an energetic, technical leader with strong… more
- Merck & Co. (Rahway, NJ)
- …extensive experience in design controls, device transfer, control strategies device risk management , and design verification testing to develop value-added ... technology transfer programs in both development and lifecycle management , ensuring compliance with relevant regulatory standards.Ensure robust technical plans, … more
- Tris Pharma (Monmouth Junction, NJ)
- …implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in design (and resolution) of key ... spanning neuroscience and other therapeutic categories employing our proprietary science and technology .Our science and technology make us unique, but our team… more
- Merck & Co. (Durham, NC)
- …goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release, Change Control).- ... Risk Mitigation:-Ensure External Partner Site Readiness, Assist with Technology Transfer, Develop and Execute Manufacturing Process Robustness Plans, Production… 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 ... of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise...immune disorders. Summary: The Senior Director, Head of RBQM ( Risk Based Quality Monitoring) sets the vision and strategy… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …supervision and conduct testing Core roles include communication, compliance, risk management , and use of current technology System Design and Specification ... is responsible for maintaining and advising new projects on the Building Management System while collaborating with the Engineering team to provide necessary… more
- Merck & Co. (San Francisco, CA)
- … Process, Managing Engineering Teams, Operational Metrics, Performance Monitoring, Project Management , Research Databases, Risk Management , Status Reporting, ... with the DSCS Digital Leadership Team to drive the execution and management of DSCS Digital initiatives.Development Sciences and Clinical Supply (DSCS) enables Drug… more
- Formation Bio (New York, NY)
- …CMOs, software vendors, and other biotech service providers. Knowledge of contract law, risk management , and compliance in vendor agreements. Ability to work ... patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug… more
- Novo Nordisk Inc. (Durham, NC)
- …and SME to operate within compliance with a quality mindset that focuses on risk management & mitigation Lead the training & implementation of effective change ... within compliance with a Quality Mindset that focuses on risk management and mitigation. Utilize the appropriate...university required May consider an Associate's Degree in Engineering Technology or a relevant field of study from an… more
- Merck & Co. (Rahway, NJ)
- …of manufacturing GMP steps, demonstration of new manufacturing technology /processes, training opportunities for improved manufacturing process development, and ... seamless technology transfer to commercial sites.The SSO Operations Specialist will...promote fast and efficient closure.As needed, safely perform High Risk Work involving hazardous energy control.Identify and follow through… more
- Merck & Co. (Rahway, NJ)
- …Inventors. Through innovative thinking, state-of-the-art facilities, cutting-edge science, and technology , we collaborate to deliver the next medical breakthroughs. ... investments in continuous manufacturing, green and sustainable processes, and proprietary technology platforms. We actively publish and engage with the scientific… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …enterprise technologies and will also be responsible for performing technical risk and vulnerability assessments at the network, system, and application level. ... responsibilities developing and implementing security controls and formulating operational risk mitigations. Relationships: Reports directly to the manager of Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … technology , healthcare/pharmaceuticals, as well as social media crisis management are preferred preferredDaiichi Sankyo, Inc. is an equal opportunity/affirmative ... unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in… more
- Merck & Co. (Rahway, NJ)
- …pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and external manufacturing sites, ... toCoordinate project planning, resourcing, progress reporting, troubleshooting and people management .Serve as the scientific/technical mentor for junior staff.- Provide… more
- Aequor (Thousand Oaks, CA)
- …and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management , and leading matrixed teams through influence to meet NPI ... NPI Lead is expected to have ownership over the Technology Transfer Project Planning, an activity that is vital...to deliver NPIs on time through effective indirect people management and effective communication, both within and outside of… more
