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The Autumn Group Staffing and Solutions · 3 months ago

R&D Quality Project Lead and Principal Business Analyst

United States

Full-time

Remote

Senior Level, Lead/Staff

5+ years exp

The Autumn Group Staffing and Solutions is a staffing and solutions company seeking an R&D Quality Project Lead and Principal Business Analyst. This role is responsible for integrating and standardizing R&D Quality operations and managing projects to improve business processes and systems within the organization.

Information and Communications Technology (ICT)Information ServicesInformation TechnologyRecruitingStaffing Agency

Responsibilities

Responsible for guiding discussions with stakeholders in order to gather and document business needs requirements. Expectation will be to analyze, research, and recommend solutions to business problems in or pertaining to R&D Quality

Analyzes data and processes, including process mapping in order to identify areas for improvement

Serves as the key conduit around communications within project teams to foster transparency and understanding between groups. Communicates with wide range of stakeholders in Quality as well as other Business areas to ensure alignment and understanding

Responsible for providing strategic input, technical and project management oversight to various functions across RDQA using project management standards (PMBOK, Lean Six Sigma)

Works with cross functional departments and colleagues to ensure consistency, adherence, communication, training and appropriate application of these project and change management tools and best practices

Responsible for the management of small, medium, and large-scale projects or process improvement initiatives. Includes enhancement and complex change management activities focused around operational excellence and organizational maturity

Identifies appropriate cross-functional project representatives and timing for engagement

Conducts extensive research and investigations around proposed changes in order to be able to understand root causes that will help identify gaps in process, outliers, anomalies, trends and patterns

Qualification

Clinical Practices (GCP)Project Management StandardsProcess MappingLean Six SigmaAgile MethodologiesStakeholder EngagementAnalytical SkillsChange ManagementMicrosoft Office ProficiencyCommunication Skills

Required

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. Places a high value on developing and cultivating strong working relationships both internally and externally

Strong working knowledge of Good Clinical Practices (GCP) with some 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

Works independently and collaboratively as part of a larger team, reporting status and elevating issues to manager where appropriate

Demonstrated proficiency using Microsoft Office applications required (including MS Word, OneNote, Excel, Project, Visio, SharePoint)

Experience running projects or working knowledge of key concepts from the following: Software Systems Development Lifecycle (SDLC), Product Lifecycle Management (PLM), Lean Six Sigma (LSS) and Agile (SCRUM/Kanban) methodologies to effectively 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, requires understanding of various quality functions such as vendor oversight, inspection readiness, risk management, and other critical to quality areas

Preferred

B.S. in a scientific, clinical focused, or other quality related field and 5-7 years of relevant technical work experience or comparable relevant background

M.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 solving business and/or compliance challenges