- Merck & Co. (Rahway, NJ)
- …Project Portfolio Management (PPM), Publications Management, Regulatory Compliance, Risk Management, Sourcing and Procurement, Strategic Planning {+ 5 ... within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level...and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings… more
- Merck & Co. (Durham, NC)
- …Support, Personal Initiative, Process Innovation, Process Optimization, Professional Integrity, Project Management, Regulatory Inspections, Risk Control ... edit technical documents to support regulatory filings including technical reports and risk assessments Author or approve Change Control documentation for… more
- Merck & Co. (Rahway, NJ)
- …Expertise:Utilize extensive experience in design controls , device transfer, control strategies device risk management, and design verification testing ... prefilled syringes, and complex drug delivery systems.Proven expertise in design controls , risk analysis, control strategies, design verification… more
- Merck & Co. (Durham, NC)
- …with Finance and Supply Chain Management to ensure budgeted funds are aligned with project spend actuals. Lead project feasibility for implementation of Team ... sectionsLead project to align pallet quantity / unit of measure (UOM) Lead project to upgrade overall discard process Primary Responsibilities, Continuous… more
- Aequor (Thousand Oaks, CA)
- …the NPI project plan(s), being accountable for NPI scope, schedule, risk management, and leading matrixed teams through influence to meet NPI project ... Manufacturing" role will serve as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems,...is expected to have ownership over the Technology Transfer Project Planning, an activity that is vital to the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile ... and productivity improvements.Support manufacturing investigations, support and manage change controls , and maintain permanent inspection readiness and actively support… more
- Novo Nordisk Inc. (Durham, NC)
- …cLEAN® tools within the main areas of Systematic Problem Solving, process improvement, & project management Serve as the Lead and SME to operate within ... compliance with a quality mindset that focuses on risk management & mitigation Lead the training & implementation of effective change management Lead Support… 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 ... to strategic initiatives; work with senior leaders to establish overall project strategy and guide teams in its execution.Conceptualize, plan, and execute… more
- Merck & Co. (Rahway, NJ)
- …of the following: process characterization (PC), process performance qualification (PPQ), risk assessment (RA), control strategy, process comparability reports, ... validation guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and external… more
- Merck & Co. (Durham, NC)
- …goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control ).- Supply ... and Activities include but are not limited to : Lead an Integrated Cross-Functional Team in Delivery of Reliable... Project Management and Virtual Collaboration Tools (Microsoft Project , OneNote, Teams, SharePoint, Action Trackers, Risk … more
- Insmed Incorporated (San Diego, CA)
- …clinical GMP drug substance and drug product production and quality control operations. This role combines technical leadership in equipment lifecycle management ... and qualification of instruments and equipment for GMP manufacturing and quality control (QC), with the flexibility to support both large-scale production systems… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and application level. Some responsibilities developing and implementing security controls and formulating operational risk mitigations. Relationships: Reports ... of 6 years of progressively responsible relevant experience Ability to lead a project in the development and implementation of processes and technology Ability… more
- Burns & McDonnell (Vancouver, WA)
- …review, negotiation, approval, and execution of prime contracts, subcontracts, and change orders. Lead internal and external project risk reviews and consult ... including overall safety, quality, engineering, procurement, construction, environmental compliance, project controls , and public/community relations. Establish … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manufacturing and project planning experience preferred.Provide technical expertise of Change Control process as well as oversight of the MES team to ensure ... be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at the… more
- Burns & McDonnell (Kansas City, MO)
- … staffing, environmental compliance, facility support and schedule attainment. Participate in and lead internal and external project risk reviews. Consult ... and monitor project schedules, manage scope, and control project costs. Serve as the primary...and implement project policies and procedures, establish project controls systems, and implement the … more
- Burns & McDonnell (Madison, WI)
- …environmental compliance, facility support and schedule attainment. Participate in and potentially lead internal and external project risk reviews. Consult ... safety, siting, environmental, permitting, planning, estimating, engineering, right-of-way acquisition, project controls , bid phase services, procurement, constructability… more
- Burns & McDonnell (Los Angeles, CA)
- …review, negotiation, approval, and execution of prime contracts, subcontracts, and change orders. Lead internal and external project risk reviews and consult ... will be responsible for project safety, quality, schedule, cost control , contracts, risk , suppliers, proposals, estimates, documentation turnover, client… more
- Burns & McDonnell (Houston, TX)
- …review, negotiation, approval, and execution of prime contracts, subcontracts, and change orders. Lead internal and external project risk reviews and consult ... day-to-day management of project safety, quality, schedule, cost control , contracts, risk , suppliers, proposals, estimates, documentation turnover, client… more
- Burns & McDonnell (Chicago, IL)
- …environmental compliance, facility support and schedule attainment. Participate in and potentially lead internal and external project risk reviews. Consult ... safety, siting, environmental, permitting, planning, estimating, engineering, right-of-way acquisition, project controls , bid phase services, procurement, constructability… more
- USAA (Phoenix, AZ)
- …filing, document governance, risk control self-assessments, procedure governance, control design, new product controls , CoSA Third Party Governance, or ... in lieu of degree. 8 years of experience in Property & Casualty, Project Management, Process Engineering, Business Process or Risk Management, to include… more
