R&D Quality Project Lead and Principal Business Analyst

R&D Quality Project Lead and Principal Business Analyst

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The R&D Quality Assurance (RDQA) Analytics and Centers of Excellence (ACE) is responsible for integrating and standardizing operations, processes, information, data, and technology to advance and align the capabilities, competencies, and outputs of R&D Quality (in the areas of GCP, GLP, GVP, Research, and Real World Evidence / Data) with high value goals / strategy and other related Quality organizations by building a robust data‑rich landscape that empowers teams through a data‑driven decision‑making culture.

This individual will evaluate future projects and initiatives for scoping, feasibility, and manage delivery of vetted and approved projects that improve business processes and systems to drive effectiveness, standardization, harmonization and improved productivity.

R&D Quality Principal Business Analyst

R&D Quality Project Lead and Principal Analyst

• Guide discussions with stakeholders to gather and document business needs and 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 for communications within project teams to foster transparency and understanding between groups.
• 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 that will help identify gaps in process, outliers, anomalies, trends and patterns.

• Ability to influence teams and drive decision‑making in a collaborative working environment.
• Communicate effectively with stakeholders, management, and LT members; partner across and within various functional departments and comfortably lead meetings and guide discussions.
• Consultative, listening, and analytical skills; forward‑thinking and innovative problem‑solving and solution development.
• Stakeholder engagement, management and business relationship management best practices; high value placed on cultivating strong working relationships both internally and externally.
• Strong working knowledge of Good Clinical Practices (GCP) with familiarity of GVP, GMP, GDP and CMC operations.
• Demonstrated use of process mapping skills to evaluate health of a process and reveal opportunities for improvement.
• Robust change management skills and ability to implement governance methodologies.
• Work independently and collaboratively as part of a larger team, reporting status and elevating issues to manager where appropriate.
• Proficiency with Microsoft Office applications required (MS Word, One Note, Excel, Project, Visio, SharePoint).
• Experience running projects or working knowledge of key concepts from Software Systems Development Lifecycle (SDLC), Product Lifecycle Management (PLM), Lean Six Sigma (LSS) and Agile (SCRUM/Kanban) methodologies to manage projects/teams of significant scope and complexity.
• May serve as Subject Matter Expert (SME) for some projects and initiatives supporting the key areas listed in the position summary, requiring understanding of various quality functions such as vendor oversight, inspection readiness, risk management and other critical quality areas.

• B.S. in a scientific, clinical focused, or other quality related field and 5-7 years of relevant technical work experience or comparable background.
• M.S. in a scientific, clinical focused, or other quality related field and 3-5 years of relevant work experience or comparable background.
• Demonstrable experience in the pharmaceutical, biotechnology or device industry solving business and/or compliance challenges.

Mid‑Senior level

Full‑time

Research, Analyst, and Information Technology

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