- Merck & Co. (Rahway, NJ)
- … management decisions and strategies.Utilize statistical methods to interpret risk data , providing clear and actionable recommendations rooted in empirical ... and apply regulatory and compliance requirements relevant to device risk management activities, ensuring adherence to industry standards.Lead risk… more
- Merck & Co. (Rahway, NJ)
- …with a team of scientists tasked with identifying, developing, and deploying data -rich technologies aimed at improving the manner in which process understanding is ... will leverage fundamental process modeling, machine learning, and other innovative data science approaches to enable our process research and development efforts… more
- Merck & Co. (Rahway, NJ)
- …/ compliance requirements relative to design controls and risk management activities. Position Qualifications: Education Minimum Requirement: BA/BS ... and supporting continuous improvement initiatives related to design control and risk management processes for combination products. This includes identifying… more
- Merck & Co. (Rahway, NJ)
- …exploring alternative ways to view and solve problems to achieve results Drive proactive risk management activities, including risk assessment, risk ... thermal and distribution qualification for pharmaceutical products.Strong understanding of risk management principles.Strong strategic and analytical thinking,… more
- Merck & Co. (Rahway, NJ)
- …compliance .Schedule Adherence: Understands schedule adherence impact and communicates risk .- Maintains a continuous improvement mindset and implements initiates ... partner groups including formulators, engineers, Quality, Safety, and Facilities management to drive overall success and performance of the...to increase efficiency or reduce risk to schedule adherence. Compliance :… more
- Merck & Co. (Rahway, NJ)
- … Process, Managing Engineering Teams, Operational Metrics, Performance Monitoring, Project Management , Research Databases, Risk Management , Status Reporting, ... Instrument data , Spotfire, Thoughtspot, data lakes, dashboards, data models, etc.).Proficiency in portfolio management software such as Planisware,… more
- Merck & Co. (Rahway, NJ)
- …Process Improvements, Clinical Supply Chain Management , Contract Management , Customer Alignment, Customer-Focused, Data Compilation, Detail-Oriented, ... , Key Performance Indicators (KPI), Materials Procurement, Medical Supply Management , Motivating Teams, Negotiation, Operational Excellence, Operational Risk … more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, Business, Change Management , Combination Products, Compliance Packaging, Cross-Cultural Awareness, Data -Driven Decision Making, ... drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment, risk… more
- ValSource, Inc. (Rahway, NJ)
- …21 CFR Part 11 compliance and latest industry expectations for data integrity. Project Management experience in managing scope, cost, schedule, quality, ... projects simultaneously. Strong understanding of EPCMV, Quality by Design and risk -and science-based approaches for compliance are desired. Experience with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities in collaboration with the CRO, feasibility team and the study team.-Assist Data Management with development of the clinical database (edit checks, CCG ... file is complete and accurate for assigned stud(ies).-Ensure that a study level operational risk management plan is in-place and applies a smart- risk taking… more
- Merck & Co. (Rahway, NJ)
- …, Packaging Procurement, Production Planning, Raw Material Sourcing, Results-Oriented, Risk Management , Strategic Sourcing, Strategic Thinking, Supply Chain ... execution of sourcing strategies and initiatives, and the relationship and performance management of strategic suppliers of MRO Services globally. You will work… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk ... Process, Manufacturing Scale-Up, Mentorship, Packaging Engineering, Process Optimization, Risk Management , Root Cause Analysis (RCA), Social Collaboration,… more
- Eisai, Inc (Nutley, NJ)
- …Drafting and Negotiation, Industry/ Regulatory Knowledge, Legal & Reputational Risk Management , Legal Knowledge, Mentoring/ People Development, Stakeholder ... privacy solutions that enable the Company's innovation while protecting data and mitigating risk . The role requires... Management (Legal/ Compliance )Eisai Salary Transparency Language:The annual base salary range for… more
- Merck & Co. (Rahway, NJ)
- …equipment and infrastructure (eg Quality risk assessment, safety assessment, data integrity, change management , etc.)Provide next-level support to CSO when ... Company (eg our Company's Manufacturing Division) to build or risk -mitigate infrastructure Position Qualifications: Education Minimum Requirement: Bachelor's degree… more
- Merck & Co. (Rahway, NJ)
- …and consensus facilitation and awareness of when to apply each.- Leverages scientific data to make disciplined risk -based decisions and shown to be capable ... Cross-Functional Teamwork, Decision Making, Drug Development, External Manufacturing, GMP Compliance , Innovation, Leadership, Life Science, Management Process,… more
- Merck & Co. (Rahway, NJ)
- …Communication, Data -Driven Decision Making, Influencing Skills, Leadership, Management Consulting, Oncology, Prioritization, Risk Management , ... strategy development, strategy execution and value realization, enterprise strategic planning, risk management , and strategic venture investments in healthcare… 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 ... Master in Business Administration or PhD preferred 4+ years of strategy management consulting experience from a top-tier firm (eg, BCG, McKinsey, Bain) Minimum… more
- Formation Bio (New York, NY)
- …regulatory requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk assessment ... will have the opportunity to establish the strategic development and operational management of Formation Bio's quality assurance program to support the growing drug… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …This role will also provide oversight of technical operations activities including data or document review, risk assessments, CAPAs, and continuous improvement ... technical problems.Evaluates quality processes and system standards to ensure compliance with applicable internal standards, industry standards, and global… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and capital expenditures (CapEx), ensuring alignment with business objectives, quality, compliance , and cost optimization. The role will work closely with ... goals. The Manager will play a key role in vendor management , contract negotiation, and operational procurement excellence.Key Responsibilities Support and lead… more
