Director, GCP Inspection Readiness Program Lead

Redbock - an NES Fircroft company; Boston (MA); On-site; USD 180,000 - 280,000; Full time

Job summary

Redbock - an NES Fircroft company seeks an experienced Director-level GCP Inspection Readiness Project Manager to drive inspection readiness for a major regulatory program. You will partner across Clinical Operations, Quality, Regulatory, and other functions to coordinate and deliver readiness activities.

The ideal candidate has 10+ years in biotech/pharma, strong program management, and exceptional communication, influencing without authority to ensure organizational preparedness for FDA/global

Qualifications

• Bachelor's degree in a scientific, healthcare, or related discipline.
• 10+ years in biotech/pharma or life sciences with GCP inspection readiness leadership.
• Experience supporting FDA/global regulatory inspections.
• Strong project management across cross-functional teams.
• Ability to influence without direct authority and drive accountability.
• Excellent verbal and written communication; senior leadership presentation experience.

Responsibilities

• Lead and coordinate GCP inspection readiness activities for ophthalmology/immunology program.
• Serve as central PM lead for inspection preparedness across functions.
• Facilitate cross-functional inspection readiness meetings and sessions.
• Track milestones, deliverables, and readiness metrics to stay on schedule.
• Collect, organize, and monitor inspection-related materials and responses.
• Manage logistics, documentation tracking, timelines, and comms plans.
• Adapt client inspection readiness tools and templates for use.
• Monitor pre-requests, due dates, storyboard progress, and presentations.
• Support front-room and back-room inspection planning and coordination.
• Identify risks/gaps and drive timely resolution.
• Provide status updates to project leadership and stakeholders.
• Support CAPA and remediation activities post-inspection when needed.

Skills

GCP inspection readiness

Project management

Regulatory inspections

Stakeholder management

Cross-functional coordination

Executive communication

Education

Bachelor's degree in a scientific, healthcare, or related discipline

Tools

CAPA management tools

Inspection readiness dashboards

Job description

Redbock - an NES Fircroft company seeks an experienced Director-level GCP Inspection Readiness Project Manager to drive inspection readiness for a major regulatory program. You will partner across Clinical Operations, Quality, Regulatory, and other functions to coordinate and deliver readiness activities.

The ideal candidate has 10+ years in biotech/pharma, strong program management, and exceptional communication, influencing without authority to ensure organizational preparedness for FDA/global