This role requires candidates who are currently authorized to work in the U.S. without sponsorship, and C2C arrangements are not accepted. EST hours are required. 

The Senior Project Manager, Quality Projects is responsible for managing multiple cross-functional GCP (Good Clinical Practice) submission and inspection readiness initiatives. This role includes organizing project teams, managing schedules, developing metrics, and preparing materials for governance meetings. The role involves close collaboration with senior leadership within the Quality function and various operational stakeholders.

Key Duties & Responsibilities

• Collaborate with Quality Leadership to define and scope submission and inspection readiness workstreams, including identifying appropriate project team members.
• Develop and manage detailed project schedules based on business needs.
• Monitor deliverables to ensure alignment with established timelines and work collaboratively with workstream leads.
• Support teams in resolving challenges as they arise and escalate unresolved project or scheduling issues to management.
• Work with teams to develop and track metrics to measure progress and identify areas requiring attention.
• Set up and facilitate regular project meetings to maintain momentum and awareness.
• Prepare and present project status updates and materials for governance meetings.

Required Education

• Bachelor’s degree in life sciences, computer science, economics, or another discipline requiring quantitative skills is preferred.

Required Experience

• 6 to 8 years of experience in the biopharmaceutical, pharmaceutical, or a related industry with a strong focus on quality and continuous improvement.
• Proven ability to organize and lead cross-functional teams toward shared goals.
• Preference for candidates with experience managing regulatory submission projects.
• Experience in cell and gene therapy is a plus.

Required Knowledge & Skills

• Demonstrated experience in hands-on project leadership.
• Proficiency with tools such as Microsoft Office Suite (Outlook, Excel, Word, SmartSheet, etc.).
• Strong interpersonal and communication skills.
• Problem-solving mindset and a passion for continuous improvement.
• High attention to detail.

Work Environment

This role is primarily remote. Candidates must be able to effectively:

• Operate a computer and manage digital communications (e.g., phone, video, messaging).
• Engage in analytical and collaborative problem-solving.
• Maintain availability during standard business hours for team engagement and project responsibilities.