The GCP Project Manager is responsible for leading and coordinating GCP 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 regulatory inspections, 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 - $100/hr
Duration: 6+ months
Travel: up to 25%
ResponsibilitesCoordination of GCP Inspection Readiness ActivitiesDevelop and execute an integrated inspection readiness plan encompassing all applicable functions.Serve as the primary point of contact for external consultants and inspection readiness vendors, overseeing timelines, scope, and deliverables.Coordinate scheduling, logistics, and materials for mock inspections and inspection readiness assessments.Partner with consulting teams to ensure consistent feedback, actionable findings, and alignment on readiness priorities.Collaborate closely with Kyverna QA to align inspection readiness activities, inspection support, and post-inspection follow-up.Drive follow-up actions from mock inspections and ensure effective implementation of corrective measures.Support the planning and execution of regulatory inspections, including coordination of front room/back room operations, SME scheduling, and document management.Manage inspection requests, communications, and documentation flow in real time during inspections.Maintain clear communication with leadership and cross-functional teams throughout the inspection process.Develop and 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.QualificationsBachelor’s degree in Life Sciences, Pharmacy, Engineering, or related discipline (advanced degree preferred).Minimum of 7+ years of experience in the biopharmaceutical industry.Proven track record of working with or managing external consulting firms for mock inspections or audit preparation.Strong understanding of ICH GCP guidelines and quality system principles.Exceptional project management and organizational skills with the ability to manage multiple, complex projects simultaneously.Strong stakeholder management and communication skills, including experience interfacing with senior leadership and external partners.Ability to translate consultant feedback into actionable internal plans.Proficiency with Microsoft Office, Smartsheet, and document/QMS systems (e.g., Veeva, DotCompliance).Collaborative, proactive, and detail-oriented approach with a focus on operational excellence.
Preferred QualificationsPMP certification or equivalent project management training.Demonstrated experience managing inspection readiness or regulatory inspections with FDA, EMA, or other health authorities.Experience in cell therapy and/or rare disease programs.Familiarity with global inspection processes and remote inspection technologies.Strong analytical mindset and commitment to continuous improvement.