Junior Operational Readiness Project Manager

Insight Global; Holly Springs (NC); On-site; USD 70,000 - 110,000; Full time

Job summary

Insight Global is seeking a Project Manager to support readiness and startup activities for a large biologics facility in Raleigh-Durham, NC. The role emphasizes execution, communication, and organization across cross-functional teams in a regulated setting.

The ideal candidate has 3–5 years of project management experience, with exposure to deviations, CAPAs, and startup readiness. This position requires strong coordination skills and the ability to influence without direct authority in a

Qualifications

• 3–5 years of project coordination or management experience.
• Experience coordinating deviations, CAPAs, and flow interrupters.
• Experience in pharmaceutical manufacturing or regulated industries.
• Ability to drive accountability across cross-functional teams.
• Knowledge of GMP-regulated environments is a plus.

Responsibilities

• Coordinate and track readiness actions for deviations and CAPAs.
• Facilitate action planning meetings and maintain trackers.
• Monitor milestones, dependencies, and due dates.
• Support inspection readiness activities and regulatory programs.
• Maintain project schedules, risk logs, and status reports.

Skills

Cross-functional coordination

Regulated manufacturing experience

Strong organizational skills

Influence without authority

Communication & collaboration

Education

Bachelor's degree in Engineering/Life Sciences/Business/PM

Tools

PowerBI

Job description

We are seeking a Project Manager to support operational readiness and startup activities for a large-scale biologics manufacturing facility in Raleigh-Durham, NC. This role is ideal for an early-career to mid-level Project Manager with experience coordinating cross-functional initiatives within regulated manufacturing environments. The selected consultant will help drive startup readiness efforts by coordinating action plans, tracking project deliverables, facilitating issue resolution, and supporting inspection readiness activities. This position is highly collaborative and focused on execution, communication, and organizational effectiveness rather than technical ownership or quality decision-making.

Key Responsibilities:

Deviation & CAPA Action Coordination

• Coordinate and track readiness-related actions associated with deviations and CAPAs.
• Facilitate action planning meetings and maintain detailed action trackers.
• Monitor dependencies, milestones, and target completion dates.
• Escalate risks, delays, or barriers impacting timely closure.
• Support stakeholders through completion of assigned actions.

Operational Flow Interrupter Resolution

• Facilitate cross-functional discussions focused on operational flow interrupters and startup challenges.
• Maintain visibility of corrective actions, ownership, due dates, and closure status.
• Identify and escalation unresolved issues impacting startup readiness.
• Ensure appropriate follow-up and accountability across stakeholder groups.

Inspection Readiness Support

• Support activities associated with regulatory inspection readiness programs.
• Assist with assessments, documentation reviews, evidence collection, and gap tracking.
• Prepare status reports and communicate progress to leadership teams.

Project Planning & Operational Readiness

• Provide project coordination support for assigned operational readiness initiatives.
• Maintain project schedules, milestone plans, risk logs, issue trackers, and dependency registers.
• Develop status updates and facilitate project review meetings.
• Support execution of startup-related deliverables and readiness activities.
• Ensure key activities remain aligned with established timelines and business objectives.

Closeout & Continuous Improvement

• Compile final project summaries, action closure reports, and risk assessments.
• Facilitate lessons learned sessions with stakeholders.
• Document improvement opportunities and recommendations for future startup initiatives.
• Support transition of outstanding actions and sustainment activities.

Required Qualifications:

• Bachelor's degree in Engineering, Life Sciences, Business, Project Management, or a related discipline.
• 3–5 years of project coordination or project management experience.
• Experience coordinating or tracking – Deviations, CAPAs, Flow interrupters, Quality/compliance activities
• Comfortable driving accountability across cross functional teams
• Able to influence without direct authority
• Experience supporting pharmaceutical manufacturing environments
• Experience supporting projects within pharmaceutical, biotechnology, medical device, food manufacturing, chemicals, or other regulated industries.
• Strong organizational skills with the ability to manage multiple priorities simultaneously.
• Experience maintaining project schedules, action trackers, risk logs, and status reports.

Preferred Qualifications:

• Experience supporting startup, commissioning, qualification, validation, operational readiness, or manufacturing readiness projects.
• Familiarity with GMP-regulated environments.
• Experience with PowerBI
• PMP, CAPM, or related project management training is a plus.