Job Description:
General Position Summary:
The RDQA Analytics Center of Excellence (ACE) is a business operations–focused, project management–driven function dedicated to supporting corporate and Quality goals. The team strengthens and scales organizational capabilities by delivering tools, systems, workflows, metrics, and data-driven solutions that enable optimal execution, portfolio management, and strategic decision-making across RDQA.
The Senior Project Manager is responsible for leading multiple mid to large scale, complex projects with multiple stakeholders across several functions that improve business processes, systems, and cross-functional operations. This role drives effectiveness, automation, standardization, harmonization, and productivity across RDQA functions. It provides both technical and strategic project management expertise to R&D sub-functions including Compliance and Issue Management, R&D Quality Risk and Patient-Centric Ethics, R&D Vendor Quality Management, Global Clinical Quality, PV and RWE Operational Quality, and GLP Biomarkers Research (GBR).
The Senior Project Manager also delivers strong project governance, status reporting, and risk management and mitigation related to architecture, workflows, governance frameworks, reporting capabilities, and technology solutions supporting these groups.
Key Responsibilities:
- Lead the oversight, execution, and successful delivery of large-scale, cross-functional, and potentially multi-year initiatives that are high impact and strategically important to the organization.
- Provide strategic input and technical expertise while applying project management best practices to support functions across RDQA.
- Partner closely with cross-functional teams to ensure alignment, consistency, compliance, communication, training, and effective change management.
- Manage large-scale projects and process improvement initiatives focused on operational excellence, organizational maturity, and scalable solutions.
- Serve as the central communication conduit across project teams to ensure transparency, clarity, and alignment.
- Identify appropriate project representatives, governance model, engagement timing, and cross-functional involvement needed for successful execution.
- Conduct research, data analysis, and root cause investigations to identify process gaps, operational risks, trends, and improvement opportunities.
- Serve as a Subject Matter Expert (SME) on medium-complexity initiatives, providing guidance on processes, systems, and analytics.
- May manage, mentor and train employees and contracting staff providing administrative / coordination assistance ensuring efficient time and resource utilization.
General Responsibilities and Required Skills:
- Bachelors degree with a minimum of 10 – 15+ years experience in project management and 5+ years of experience in clinical research and/or the pharmaceutical or biotech industry
- Strong ability to influence teams, facilitate decision-making, and drive progress in a collaborative environment while maintaining appropriate stakeholder engagement.
- Excellent communication skills, including the ability to engage effectively with senior leadership and partner across diverse functions
- Ability to influence teams and drive decision-making in a collaborative working environment and allows for the appropriate levels of involvement and decision-making
- Experience leading or contributing to projects using proven project management methodologies such as Product Lifecycle Management (PLM), Lean Six Sigma (LSS), Agile (SCRUM/Kanban) and Software Development Lifecycle (SDLC).
- Demonstrated consultative, analytical, and forward-thinking capabilities to support innovative problem-solving and solution design.
- Expertise in stakeholder engagement, business relationship management, and building productive internal and external partnerships.
- Strong working knowledge of clinical and preclinical research operations, GCP, and general familiarity with GVP, GMP, GDP, and CMC frameworks.
- Proficiency with communication, change management, risk management and mitigation and process mapping and process optimization methodologies.
- Ability to work independently, provide transparent status updates, and escalate risks or issues appropriately.
- Proficiency with Microsoft Office applications including MS Visio, Smartsheets, OneNote, Excel, MS Project, and SharePoint.
Preferred Education and Experience:
- Masters degree or MBA and 7–10+ years of experience in clinical research
- Certification in proven project management principles and methodologies (PMP, CPIP, CPGP, ACPMC, PMI, Six Sigma (green / black belt)
- 10+ years experience in the Biotech or Pharmaceutical Industry or relevant comparable background.
- Experience in Quality Assurance within the biotech industry
