Director, GCP Inspection Readiness Project Manager

Redbock - an NES Fircroft company; Boston (MA); Vor Ort; USD 180.000 - 280.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

GCP inspection readiness

Project management

Regulatory inspections

Stakeholder management

Cross-functional coordination

Executive communication

Ausbildung

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

Tools

CAPA management tools

Inspection readiness dashboards

Jobbeschreibung

Our client is seeking an experienced Director-level GCP Inspection Readiness Project Manager to support inspection readiness activities for the company's upcoming 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 our client's ophthalmology/immunology 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.