Regulated Life Sciences Project Manager — Readiness

PSC Biotech® Corporation

Raleigh (NC)

On-site

USD 90,000 - 130,000

Full time

34 hours ago
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Job summary

PSC Biotech® Corporation is seeking an experienced Project Manager to support cross-functional readiness and inspection readiness initiatives within a regulated life sciences environment.

You will coordinate action plans, track milestones, manage risks, and provide governance for assigned initiatives, while collaborating with Quality, Manufacturing, Engineering, and Supply Chain teams to ensure timely execution.

Qualifications

  • Bachelor's or advanced degree in engineering or related life sciences.
  • PMP certification is a plus.
  • 3-7 years of project management experience within the regulated Life Sciences industry.
  • Experience coordinating complex, cross-functional projects involving multiple stakeholders.
  • Strong knowledge of scheduling, risk management, issue tracking, dependency management, and status reporting.
  • Excellent verbal and written communication skills, with experience presenting project updates to leadership teams.
  • Must be authorized to work in the US.
  • No C2C at this time.

Responsibilities

  • Coordinate action plans, track milestones, manage risks and dependencies.
  • Facilitate action planning meetings and ensure alignment of stakeholders on priorities, timelines, and deliverables.
  • Monitor project schedules, dependencies, milestones, and due dates to support timely completion of assigned activities.
  • Identify, communicate, and escalate project risks, barriers, and unresolved issues that may impact readiness objectives.
  • Facilitate cross-functional triage and resolution sessions for operational flow interrupters and business-critical challenges.
  • Track corrective actions, ownership, and closure status while maintaining visibility through project reporting tools and dashboards.
  • Support inspection readiness activities through action tracking, gap assessment coordination, documentation management, evidence collection, and stakeholder preparation activities.
  • Maintain and communicate project status updates, key performance indicators, action trackers, and leadership reports.
  • Support operational readiness initiatives by managing approved work plans, milestone schedules, risk registers, and dependency tracking.
  • Collaborate with Quality, Manufacturing, Engineering, Supply Chain, Validation and other functional teams to drive alignment and execution.
  • Facilitate lessons learned sessions and document recommendations for process improvements and future readiness efforts.
  • Prepare final project summaries outlining completed activities, residual risks, open actions, and recommended next steps.

Skills

Project management
Cross-functional coordination
Risk management
Stakeholder communication
Meeting facilitation

Education

Bachelor's or advanced degree in engineering or life sciences

Job description

PSC Biotech® Corporation is seeking an experienced Project Manager to support cross-functional readiness and inspection readiness initiatives within a regulated life sciences environment.

You will coordinate action plans, track milestones, manage risks, and provide governance for assigned initiatives, while collaborating with Quality, Manufacturing, Engineering, and Supply Chain teams to ensure timely execution.

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