GCP Inspection Readiness Director (Part-Time)

Redbock - an NES Fircroft company; Waltham (MA); On-site; USD 152,000 - 193,000; Part time

Job summary

Redbock - an NES Fircroft company in Massachusetts is seeking an experienced Director-level GCP Inspection Readiness Project Manager to coordinate readiness activities for the elegrobart regulatory program. This role partners across Clinical Operations, Quality, Regulatory and other stakeholders.

You will lead inspection readiness efforts, manage timelines, track milestones, and ensure preparedness for potential health authority inspections.

Qualifications

• Bachelor's degree in a scientific or healthcare-related field.
• 10+ years in biotechnology/pharma or life sciences organizations.
• Led GCP inspection readiness programs at sponsor level.
• Experience supporting FDA/global regulatory authority inspections.
• Strong cross-functional project management capabilities.
• Outstanding verbal and written communication skills.
• Ability to influence without direct authority and drive accountability across teams.

Responsibilities

• Lead and coordinate GCP inspection readiness activities for the elegrobart program.
• Serve as central PM for inspection preparedness across functions.
• Facilitate cross-functional inspection readiness meetings and sessions.
• Track milestones, deliverables, action items, and readiness metrics.
• Collect, organize, and monitor inspection-related materials and responses.
• Manage inspection readiness logistics, timelines, and comms plans.
• Utilize established inspection readiness tools and templates.
• Monitor pre-requests, deliverables, due dates, storyboard progress, and readiness activities.
• Support front-room and back-room inspection planning and coordination.
• Identify risks and gaps; proactively drive resolution with status updates to leadership.
• Support post-inspection CAPA and remediation activities when required.

Skills

GCP inspection readiness

Project management

Cross-functional leadership

Regulatory inspections

Stakeholder management

Communication

Influence without authority

Education

Bachelor's degree in scientific/healthcare field

Job description

Redbock - an NES Fircroft company in Massachusetts is seeking an experienced Director-level GCP Inspection Readiness Project Manager to coordinate readiness activities for the elegrobart regulatory program. This role partners across Clinical Operations, Quality, Regulatory and other stakeholders.

You will lead inspection readiness efforts, manage timelines, track milestones, and ensure preparedness for potential health authority inspections.