Redbock, an NES Fircroft company, is seeking a Project Manager for their R&D Quality Assurance Analytics and Centers of Excellence function. The consultant will drive operational excellence and process standardization while leading projects to improve R&D QA processes and systems.
Responsibilities:
- Support R&D QA Centers of Excellence operations, including process standardization, information management, and operational alignment with corporate and Quality initiatives
- Evaluate business needs and lead projects that improve R&D QA processes, systems, and operational effectiveness
- Analyze workflows and perform process mapping to identify gaps, trends, and opportunities for improvement
- Develop and enhance training systems, including role-based curricula and procedural documentation (SOPs, work instructions, job aids)
- Create and maintain operational tools such as templates, trackers, financial/resource planning tools, and reporting dashboards
- Partner with stakeholders to gather business requirements, recommend solutions, and coordinate project execution
- Facilitate cross-functional collaboration and communication across R&D QA and broader Quality teams
- Support change management initiatives and adoption of standardized project and process management practices
- Conduct research and root cause analysis to support process improvements, compliance initiatives, and strategic decision-making
Requirements:
- BS degree minimum; 5-10 years of biotechnology industry experience required
- Strong understanding of clinical trial operations and Good Clinical Practice, with familiarity in GVP, GMP, GDP, and CMC environments
- Demonstrated project management experience supporting R&D, QA, process improvement, business analysis, or operational excellence initiatives
- Proficiency with Microsoft Office tools including Excel, Project, Visio, SharePoint, and Smartsheet
- Experience working with project or process frameworks such as SDLC, PLM, Lean Six Sigma, or Agile (Scrum/Kanban)
- Strong communication, stakeholder management, and analytical skills with the ability to work across cross-functional teams
- Advanced degree is preferred