GCP Project Manager (Contract)

Responsibilites

• Coordination of GCP Inspection Readiness Activities
• Develop 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.

Qualifications

• Qualifications
• Bachelor’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 Qualifications
• PMP 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.