- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you.The Director, Global IT Governance, Risk & Controls Management Lead is responsible for overseeing the entire portfolio ... Oversight : Assess and oversee IT compliance responsibilities, providing risk assessments.Policy Development: Develop and implement policies, procedures, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary The Oncology Early Development Center (OEDC) Program Lead , who directly reports to the Head of the OEDC, supports the OEDC ... with an equally robust and agile infrastructure. The Program Lead plays a central role in supporting OEDC to...strategy and execution for DS. This position provides direct oversight of the internal OEDC staff necessary for meeting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …expertise and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems ... timelines and resource requirements for CSV projects. Work within a risk -based framework (Computer Software Assurance (CSA)) that is compliant with global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to exercise influence at ... GLP/non-GLP/ Research submissions to Health authorities globally. Provide QA oversight of GLP/GCLP activities of Daiichi Sankyo, contract research organization/… more
- Eisai, Inc (Nutley, NJ)
- …Security Engineer is responsible for building out the organizational capabilities to lead and manage Eisai's security engineering activities related to Identity & ... overall security objectives and industry best practices.2. Leadership and management: Lead a team of infrastructure technical security professionals across the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary / Objective Serves as a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the ... are conducted by the Contract Research Organization (CRO) Medical Monitor (MM):- Provides oversight to the CRO MM for clinical data review activities- May support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Job Summary: Serves as a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the ... are conducted by the Contract Research Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical trials. Serves as a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the ... are conducted by the Contract Research Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support… more
- Merck & Co. (Rahway, NJ)
- …(Design Control per ISO 13485, QMSR, Part 4). Lead quality oversight of product validation, verification, and risk mitigation activities.Regulatory CMC ... requirements throughout the product design, development, and manufacturing processes.Implement risk management principles (ISO 14971) in design and development to… more
- Merck & Co. (Rahway, NJ)
- …plan. This role represents an excellent opportunity for a leader seeking to lead a team of talented scientists, provide oversight to multiple programs, ... within the Development Sciences and Clinical Supplies (DSCS) organization and lead a group of exceptionally talented scientists supporting externalized analytical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Senior Global Safety Scientists and Safety Scientists. Contributes and provides oversight in the development of safety strategy and safety deliverables for ... level. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of safety profile of assigned molecules/products and… more
- Merck & Co. (Rahway, NJ)
- …globally. We are currently recruiting for an Associate Vice President (AVP) to lead global marketing for our Global Ophthalmology Franchise.For more than 35 years, ... and treatment of vision loss associated with retinal vascular leakage, a known risk factor for retinal diseases.This is an exciting opportunity to help patients and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …processes meet highest standards by working cross functionally and managing the oversight of all required processes Designs and promotes systems to continuously ... reports in audit/inspection preparedness and participation Serves as NAO's Lead regarding FDA and Health Canada safety reporting responsibilities Directs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …from Request for Proposal (RFP) to final contract. This position has direct oversight and accountability of Category leads to drive and execute sourcing activities ... policies and methodologies are understood and utilized. Serve as the lead "relationship manager" to proactively deliver strategic sourcing insights, optimal value… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at the ... experience preferred.Provide technical expertise of Change Control process as well as oversight of the MES team to ensure smooth implementation of system enhancement… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Supervisor is an exempt level position with responsibilities for providing quality oversight over the production of personalized cell therapy to support both ... corrective and preventive actions, as necessary.Supports internal/external audits.Supports Quality risk assessment teams.Review/approve documents as a Quality on the… more
- Aequor (Thousand Oaks, CA)
- …Site performance monitoring: Report contract site performance metrics to site lead ; identify improvement opportunities for site performance; daily duties will ... standardization of performance tools used by the Work Center Teams (WCT), oversight and reporting of procurement/payment of invoices, and active participation in WCT… more
- Aequor (Louisville, KY)
- …critical facility equipment and key computerized systems Identify, support, and/or lead implementation of engineering based improvements or upgrades to the equipment ... closeout Monitor systems to identify performance risks and implement risk reduction strategies Support new product/technology introductions by performing engineering… more
- Tris Pharma (Monmouth Junction, NJ)
- …deviations and PQC investigations relating to production operations, quality operations oversight and quality control analysis and overseeing and ensuring timely, ... improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and resolution) of key quality… more
- Bank of America (Denver, CO)
- Risk Oversight Lead Washington, District of Columbia;Chicago, Illinois; Denver, Colorado **Job Description:** At Bank of America, we are guided by a common ... Join us! **Position Overview:** Individual contributor role serving as the functional lead for the Risk Oversight team within PCG External Engagement & … more
