Director, GCP Inspection Readiness & Cross-Functional PM

Redbock - an NES Fircroft company; Waltham (MA); On-site; USD 96,000 - 165,000; Part time

Job summary

Redbock - an NES Fircroft company seeks an experienced Director-level GCP Inspection Readiness Project Manager to drive inspection readiness for the elegrobart regulatory program. You will partner across Clinical Operations, Quality, Regulatory, and other stakeholders to coordinate timelines and deliverables.

The role emphasizes leadership in inspection readiness, managing cross-functional activities, and delivering clear executive communications in a fast-paced environment.

Qualifications

• Bachelor's degree in a scientific, healthcare, or related discipline.
• 10+ years of experience within biotechnology, pharmaceutical, or life sciences organizations.
• Significant experience leading GCP inspection readiness programs at the sponsor level.
• Demonstrated experience supporting FDA and/or global regulatory authority inspections.
• Strong project management experience coordinating complex, cross-functional initiatives.
• Outstanding verbal and written communication skills.

Responsibilities

• Lead and coordinate GCP inspection readiness activities for the elegrobart program.
• Serve as the central project management lead for inspection preparedness initiatives across functions.
• Facilitate cross-functional inspection readiness meetings and working sessions.
• Track milestones, deliverables, action items, and readiness metrics to keep activities on schedule.
• Partner with internal stakeholders to collect, organize, and monitor inspection-related materials and responses.
• Manage inspection readiness logistics, documentation tracking, timelines, and communication plans.
• Utilize inspection readiness tools, processes, and templates developed during previous activities.
• Monitor pre-requests, deliverables, due dates, storyboard progress, and readiness activities.
• Support front-room and back-room inspection planning and coordination efforts.
• Identify risks, gaps, and readiness issues and drive timely resolution.
• Provide clear status updates and executive-level communications to leadership.
• Support post-inspection CAPA and remediation activities when required.

Skills

GCP inspection readiness

Project management

Stakeholder management

Cross-functional coordination

Regulatory inspections (FDA)

Executive communication

Influence without authority

Education

Bachelor's degree in a scientific/healthcare related discipline

Job description

Redbock - an NES Fircroft company seeks an experienced Director-level GCP Inspection Readiness Project Manager to drive inspection readiness for the elegrobart regulatory program. You will partner across Clinical Operations, Quality, Regulatory, and other stakeholders to coordinate timelines and deliverables.

The role emphasizes leadership in inspection readiness, managing cross-functional activities, and delivering clear executive communications in a fast-paced environment.