United States onlyThe 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%
Responsibilites
- 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
- Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related discipline (advanced degree preferred).
- 7+ years of experience in the biopharmaceutical industry, including 3+ years in GCP or GMP quality/compliance roles.
- Demonstrated experience managing inspection readiness or regulatory inspections with FDA, EMA, or equivalent agencies.
- Proven track record of working with or managing external consulting firms for mock inspections or audit preparation.
- Deep understanding of GCP and GMP regulations, ICH guidelines, and quality system principles.
- Exceptional project management and organizational skills with the ability to manage multiple, complex projects.
- Strong stakeholder management and communication skills, including 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 Qualifications
- PMP certification or equivalent project management training.
- Experience in cell therapy and/or rare disease.
- Familiarity with global inspection processes and remote inspection technologies.
- Strong analytical mindset and commitment to continuous improvement.
