Vertex Pharmaceuticals

Senior Manager, R&D Quality Project Lead

Vertex Pharmaceuticals

contract

Posted on:

Origin:  • 🇺🇸 United States

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Salary

💰 $75 - $85 per hour

Job Level

Senior

Tech Stack

Google Cloud PlatformSDLC

About the role

  • Evaluate future projects and initiatives for scoping, feasibility, and manage delivery of vetted and approved projects
  • Guide discussions with stakeholders to gather and document business needs requirements
  • Analyze, research, and recommend solutions to business problems in or pertaining to R&D Quality
  • Analyze data and processes, including process mapping to identify areas for improvement
  • Serve as the key conduit around communications within project teams to foster transparency and understanding between groups
  • Communicate with wide range of stakeholders in Quality and other Business areas to ensure alignment and understanding
  • Provide strategic input, technical and project management oversight to various functions across RDQA using project management standards (PMBOK, Lean Six Sigma)
  • Work with cross functional departments and colleagues to ensure consistency, adherence, communication, training and appropriate application of project and change management tools and best practices
  • Manage small, medium, and large-scale projects or process improvement initiatives, including enhancement and complex change management activities focused around operational excellence and organizational maturity
  • Identify appropriate cross-functional project representatives and timing for engagement
  • Conduct extensive research and investigations around proposed changes to understand root causes and identify gaps in process, outliers, anomalies, trends and patterns

Requirements

  • EXPERTISE in Smartsheets
  • experience in Clinical (Operational) Quality
  • Ability to lead AND execute a project
  • Ability to influence teams and drive decision-making in a collaborative working environment
  • Communicate effectively with stakeholders, management, and LT members
  • Able to partner across and within various functional departments
  • Comfortable leading meetings and guiding discussions
  • Consultative, listening, and analytical skills; able to be forward-thinking and engage in innovative problem solving and solution development
  • Stakeholder Engagement, management and Business Relationship Management best practices
  • Strong working knowledge of Good Clinical Practices (GCP) with some familiarity of GVP, GMP, GDP and CMC operations
  • Demonstrated use of process mapping skills
  • Robust change management skills and ability to implement governance methodologies
  • Demonstrated proficiency using Microsoft Office applications (MS Word, OneNote, Excel, Project, Visio, SharePoint)
  • Experience running projects or working knowledge of: SDLC, PLM, Lean Six Sigma, Agile (SCRUM/Kanban)
  • May serve as SME for some projects and initiatives
  • PREFERRED: S. in a scientific, clinical focused, or other quality related field and 5-7 years of relevant technical work experience or comparable relevant background
  • ALTERNATIVE PREFERRED: S. in a in a scientific, clinical focused, or other quality related field and 3-5 years of relevant work experience or comparable relevant background
  • Demonstrable experience in the pharmaceutical, biotechnology or device industry