Operational Readiness Project Manager

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 escalate 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.
• Coordinate readiness actions across multiple departments.
• 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.
• Smartsheet 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.