Project Manager - GCP Inspection Readiness

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

20 hours a week to start but could grow to 30-40 a week as work starts to pick up (October,November time frame)

Position Summary

Our client s is seeking an experienced Director-level GCP Inspection Readiness Project Manager to support inspection readiness activities for the company's upcoming elegrobart regulatory program. This individual will play a highly visible role, partnering across Clinical Operations, Quality, Regulatory, and other key stakeholders to coordinate and drive inspection readiness activities.

The ideal candidate is a seasoned GCP inspection readiness professional with exceptional project management, communication, and stakeholder management skills. This role is not responsible for CRO oversight, TMF review, or BLA submission readiness activities. Instead, the focus will be on orchestrating inspection readiness efforts, managing timelines and deliverables, tracking critical activities, and ensuring organizational preparedness for potential health authority inspections.

This individual must be comfortable operating in a fast-paced environment, influencing without authority, and tactfully driving accountability across multiple functional teams.

Key Responsibilities

• Lead and coordinate GCP inspection readiness activities supporting the client's elegrobart program.
• Serve as the central project management lead for inspection preparedness initiatives across multiple functions.
• Facilitate cross-functional inspection readiness meetings and working sessions.
• Track milestones, deliverables, action items, and readiness metrics to ensure inspection preparedness activities remain 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 and adapt to the client's established inspection readiness tools, processes, and templates developed during previous inspection activities.
• Monitor inspection pre-requests, assigned deliverables, due dates, storyboard progress, presentation development, and readiness activities.
• Support front-room and back-room inspection planning and coordination efforts.
• Identify risks, gaps, and potential readiness issues and proactively drive resolution.Provide clear status updates and executive-level communications to project leadership and key stakeholders.
• Support post-inspection CAPA and remediation activities when required.

Required 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.
• Proven ability to manage competing priorities and drive deliverables across multiple stakeholder groups.
• Outstanding verbal and written communication skills.
• Experience facilitating senior leadership discussions and presenting inspection readiness status to executive stakeholders.
• Strong organizational skills with exceptional attention to detail.
• Ability to influence without direct authority and effectively drive accountability.

Preferred Qualifications

• Prior Director-level or equivalent leadership experience.
• Experience supporting late-stage clinical development programs and pivotal studies.
• Hands-on experience coordinating front-room and back-room inspection activities.Experience managing inspection readiness tools, trackers, dashboards, and governance processes.
• Familiarity with CAPA management and remediation planning following regulatory inspections.
• Ability to quickly adapt to established inspection readiness frameworks and processes.

What Will Make Someone Successful

The ideal consultant is a proactive "chaser" who is comfortable following up across the organization to obtain information, resolve obstacles, and keep readiness activities moving forward. They possess the diplomacy and professionalism to work effectively with senior stakeholders while maintaining accountability for critical deliverables and timelines.

Success in this role will come from:

• Driving execution without direct authority.
• Maintaining visibility across a large number of moving pieces.
• Ensuring inspection readiness activities remain on track.
• Building strong relationships across functional teams.
• Providing structure, organization, and communication during highly visible readiness efforts.