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The GMP Quality Operations Director serves as a Quality leader in the areas of process validation, and equipment validation in oral solid dosage form. The Director is also responsible for managing multiple department activities with a high degree of independence while providing oversight of the development, implementation, and maintenance of relevant quality initiatives i
Posted 28 days ago
The Training Associate Director is responsible for supporting the oversight of all Training related activities within the Global Regulatory Affairs organization. This role will work to create, curate, and deliver top notch learning experiences including both technical and professional development for the team. The Training Associate Director will report directly to the Se
Posted 28 days ago
The Director, Modeling & Simulations (M&S) Pharmacometrics will be responsible forindependently determining, planning, and executing M&S analyses for an entire drug development program in close collaboration with cross functional colleagues within the R&D organization. In this role, it is expected that the incumbent will represent M&S with cross functional drug developmen
Posted 28 days ago
Lead and ensure successful development and implementation of the commercialization (midterm) and portfolio (long term) strategies including brand development, competitive strategy, go to market/launch, and lifecycle decisions for future launches. Executed in close partnership with the Regions, Market Access, Regulatory and Commercial Manufacturing. Develop strong partners
Posted 1 month ago
Build and manage a manufacturing engineering team for DSDP cells and combination products Act as primary technical and engineering manufacturing lead design reviews, documentation with focus on designing for manufacturability. Implement, propose and drive the implementation of Drug Product Device and manufacturing engineering controls by integrating Vertex QMS, production
Posted 1 month ago
The Package Engineering Senior Manager is an emerging professional within the department. This role delivers on complex outsourced manufacturing activities in Packaging and is responsible for ensuring positive and effective relationships with all stakeholders. This role will focus primarily on commercializing cell & gene therapy products and preparing pipeline products fo
Posted 1 month ago
The Process Engineering Manager delivers reliably and responsibly on independent activities and is responsible for execution and oversight of internal or external manufacturing operations in a technical area. The incumbent is a key participant on internal and external cross functional teams within their technical area for one or more supplier(s). The role assists in maint
Posted 1 month ago
Provides comprehensive expertise and guidance in designated therapeutic area(s) and Vertex medicines Leads a team of physicians and scientists to create and execute appropriate medical affairs plans and tactics supporting designated therapeutic area(s) and Vertex medicines Develops and maintains professional relationships with local Health Care Professionals, and with loc
Posted 1 month ago
The Associate Director, Information Systems Management entails providing risk based oversight to Computerized Systems Life Cycle activities across broad spectrum of technologies ranging from Automated Systems to Enterprise Wide systems and Software as a Service (SaaS) solutions. This role ensures risk based, overall integrity of electronic data across all stages of data l
Posted 1 month ago
Develop engagement strategy and account plans to ensure success with target IDNs, GPOs and GPO aggregate accounts Engage with IDN, GPO and GPO aggregate account leadership, formulary decision makers, and population health stakeholders to ensure timely access and contracting, support product uptake, drive systemic change, and pursue creative partnerships, as appropriate Co
Posted 1 month ago
Identify and develop technical solutions to enable program and company goals. Contribute to the design and implementation of efficient and scalable manufacturing processes for commercial application, working closely with cross functional teams including process development, manufacturing, and engineering. The role includes the design and execution of process scale up stra
Posted 1 month ago
The Executive Director, HEME Global Strategy will have global responsibility to build the Global Medical strategy for Exa Cel. Communicate the Global Medical strategy to partner functions for further strategic and tactical guidance. Execute the Global components of the medical strategy plan. Partner with Clinical Development, HEOR, RWE, Regional Medical Affairs and partne
Posted 1 month ago
Lead the drafting/development of key abstracts, posters, congress presentations, and manuscripts Coordinate with cross functional teams and key stakeholders to achieve publication objectives Manage publication development timelines and content development associated with abstracts, posters, oral presentations, and manuscripts Responsible for the execution of the global pu
Posted 1 month ago
As a key Team Manager and leader in the Strategic Sourcing function, the Executive Director, Manufacturing & Supply Strategic Sourcing leader is responsible for elevating global business partnerships with an enterprise lens while focusing on enabling business outcomes and integrating relevant category strategies. This role will lead multiple direct reports that have teams
Posted 1 month ago
The Sr. Quality Manager is an advanced technical resource in the principles and application of quality assurance and compliance. The Sr. Quality Manager coordinates or executes activities on multiple complex projects and takes a role in the design and execution of new projects , effectively ensuring alignment with corporate goals and compliance with all regulatory require
Posted 1 month ago
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