R&D Quality Project Lead and Principal Business Analyst

Position: R&D Quality Project Lead and Principal Business Analyst
Location: Remote
Job Type: Contract
Duration: 12 months to start

Job Description
The R&D Quality Project Lead and Business Analyst role will be responsible for managing and delivering several clinical quality related projects and initiatives in order to improve business processes to drive effectiveness, standardization, harmonization and improved productivity across RDQ, (may include project management support of Inspection Readiness activities). This role provides technical and project management oversight and support for R&D sub-functions such as Compliance and Issue Management, Quality Risk Management and Patient-Centric Ethics, Vendor Quality Management (including GLP, Biomarkers, and Research), Global Clinical Quality, GVP and Real-World Evidence.

Strong Project Management and Business Analyst skills, along with a robust understanding of Clinical Quality related concepts is required to be successful in this position to support the entire lifecycle of a project from initial ideation, scoping, and feasibility to management, delivery, and governance. Significant experience working with Smartsheet in a project management capacity is required as our projects are managed using this tool. Specific experience and expertise in Inspection Readiness is a plus.

KEY RESPONSIBILITIES:

• Manage a portfolio of small to large scale projects and process improvement initiatives that advance operational excellence and organizational maturity with R&D Quality.
• Execute individual projects and initiatives, including process optimization, workflow improvements, and analytics supported solutions in collaboration with the Analytics Team.
• Partner with stakeholders to define and document business needs and translate requirements into actionable project plans that strengthen RDQ capabilities.
• Provide strategic input and structured project management oversight across RDQ functions, applying principles from Lean Six Sigma, Agile, PMBOK frameworks to ensure consistency and accountability.
• Evaluate and map existing processes to identify gaps, inefficiencies, and improvement opportunities through data driven analysis.
• Support implementation and operationalization of process improvement initiatives, ensuring effective change management and sustainable adoption across RDQ teams.
• Serve as a central communication conduit to ensure transparency, alignment, and clear information flow among project teams, stakeholders, and leadership.
• Collaborate across quality functions and with executive management to embed project management and change management best practices in day-to-day operations.
• Capture lessons learned and promote knowledge sharing to support continuous improvement, operational consistency, and long-term organizational learning.
• Partner closely with the Analytics teams to leverage data insights, support project decision making, and ensure alignment of process improvement and operational initiatives across RDQ.
• Further develop and refine templates, tools, and processes in support of robust project management for R&D Quality.
• May support implementation and operationalization of solutions to meet strategic business inspection readiness needs as well as operational pain points.
• May support functional groups accountable for oversight of programs entering an inspection planning, readiness and preparedness phase (1 year prior to submission).

GENERAL RESPONSIBILITIES AND REQUIRED SKILLS:

• Demonstrated experience in project management, whether working within or helping to establish a Project Management Office (PMO), or managing cross-functional initiatives, with a focus on project governance, prioritization, change management, and execution excellence.
• Experience managing projects of significant scope and complexity, with working knowledge of project lifecycle management and familiarity with methodologies such as Lean six Sigma and Agile to effectively guide teams and deliver results.
• Strong working knowledge of Good Clinical Practices (Google Cloud Platform) with some familiarity of GVP, GMP, GDP and CMC operations.
• Proven ability to influence and drive decision-making in collaborative, cross functional environments.
• Builds strong partnerships across all levels of the organization and with external stakeholders.
• Combines consultative communication and analytical insight with forward-thinking problem solving to develop innovative, effective solutions.
• Strong business analysis and process mapping skills to evaluate process health, identify inefficiencies, and recommend opportunities for improvement.
• Demonstrated proficiency using Smartsheet and Microsoft Office applications is required (including MS Word, OneNote, Excel, Project, Visio, SharePoint).

PREFERRED EDUCATION AND EXPERIENCE:

• B.S. in a scientific or quality related field and 5-7 years of relevant work experience or comparable relevant background.
• M.S. in a scientific or 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.
• US FDA inspections experience is a plus and/or inspection experience in Asia/Pac.

Talent Groups is an equal opportunity employer that values diversity and inclusion. All qualified applicants will receive consideration without regard to protected characteristics. The listed compensation range represents a good-faith estimate and may vary based on experience, skills, education, certifications, market conditions, client budget, and location, in accordance with applicable pay transparency laws.