GCP / GMP Inspection Project Lead (Contract)

GCP / GMP Inspection Project Lead (Contract)

The GCP / GMP Inspection Project Lead is responsible for leading and coordinating all GCP and GMP inspection readiness activities and serving as the primary liaison between the company and external consulting partners. This role ensures that the organization, its systems, and teams are fully prepared for regulatory inspections through proactive planning, coordination, and continuous improvement.

The ideal candidate brings a strong understanding of both clinical and manufacturing quality principles, exceptional project management skills, and the ability to communicate effectively across internal and external stakeholders.

Location : Emeryville, CA (Hybrid twice a week) or Remote with travel

Department : Clinical Ops / Quality Assurance

Reports to : Sr. Director, Clinical Operations

Hourly Range : $80 / hr - $120 / hr

Duration : 6+ months

Travel : up to 50%

Responsibilities

• Inspection Readiness & Coordination of Activities
• Develop and execute an integrated GCP / GMP inspection readiness plan covering all applicable functions.
• Serve as the primary point of contact for external consultants and inspection readiness vendors, managing timelines, scope, and deliverables.
• Coordinate scheduling, logistics, and materials for mock inspections and readiness assessments.
• Partner with consulting teams to ensure consistent feedback, actionable findings, and alignment on readiness priorities.
• Drive follow-up actions from mock inspections and ensure corrective measures are implemented effectively.
• Support the planning and execution for actual regulatory inspections, including coordination of front room / back room activities, SME scheduling, and document management.
• Support inspection requests, communications, and documentation flow in real time during inspections.
• Maintain clear communication with leadership and cross-functional teams throughout the inspection process.
• Maintain inspection readiness dashboards, metrics, and status reports for leadership visibility.
• As needed :
• Coordinate and track inspection findings, responses, and CAPA implementation.
• Partner with Quality, Clinical, Technical Operations, and Regulatory teams to ensure timely closure of commitments.

Qualifications