The Senior Project Manager, RAQA

What you will do:

• Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project.
• Record detailed customer requirements, constraints, and assumptions with stakeholders in order to establish the project deliverables.
• Demonstrated experience developing, managing, and communicating detailed project budgets, including forecasting, variance tracking, and financial reporting at the project level.
• Ensure a common understanding by setting expectations in accordance with the project plan in order to align the stakeholders and team members.
• Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle.
• Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques in order to keep the project plan accurate, updated, and reflective of authorized changes to facilitate customer acceptance.
• Responsible to improve team performance by building team cohesiveness, leading, influencing, training, mentoring, and motivating in order to facilitate cooperation, ensure project efficiency, and boost morale.
• Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders.
• May coordinate the activities of one or more exempt and/or non-exempt employees.

What you need

• Bachelor’s degree (BA or BS) in management, business, or a related discipline.
• 7 - 9 years demonstrated project management experience in at least one discipline (Procurement, Research & Development (R&D), Operations).
• Experience working in an FDA‑regulated and/or highly regulated environment, including familiarity with EU regulatory requirements, ISO standards (e.g., ISO 13485), FDA regulations.
• Proven ability to analyze and resolve complex process and/or system issues using independent judgment.

Preferred

• PMP certification or equivalent (i.e. PRINCE2) desired.
• Excellent interpersonal communication, collaborative teamwork and negotiation skills.
• Ability to build trusting relationships with mid -level management.
• Demonstrated experience in presenting to executives.
• Utilize proper software to maintain project records such as PPM system, MS Office, SharePoint, or Visio.

Posted: March 23, 2026