Senior Project Manager - Onsite

ProPharma GroupRaleigh, NC
Onsite

About The Position

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Requirements

  • Project management leadership, coordination, communication, and project execution support.
  • Knowledge of Cell and Gene therapy processing for commissioning, qualification, and validation of processes.

Responsibilities

  • Partner with the Engineering PM to support completion of commissioning, qualification, and turnover activities required for facility occupancy and operational readiness.
  • Coordinate project activities among contractors, stakeholders, and the Engineering PM to facilitate issue resolution, drive accountability, and maintain project momentum.
  • Support maintenance of the integrated project schedule, including tracking milestones, commitments, dependencies, and critical-path activities.
  • Maintain project controls and deliverables, including issue and risk logs, action-item tracking, communications plans, governance materials, and project status reporting.
  • Monitor project progress against key objectives and escalate schedule, resource, and stakeholder issues as appropriate to support achievement of occupancy and operational readiness goals.
  • Develop project updates and other communications for leadership stakeholders (as requested) and CCE departmental leadership.
  • Facilitate project governance and stakeholder meetings, document decisions and action items, and monitor follow-through on commitments.
  • Leverage knowledge of Cell and Gene therapy processing for commissioning, qualification, and validation of processes to proactively identify project risks, remove obstacles, and support successful execution of CQV and EMPQ activities.
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