Senior Product Marketing Manager – ICM
CaptivateIQ
GCP/GMP Inspection Project Lead – Contract
Kyverna Therapeutics
contract
Posted on:
Location Type: Hybrid
Location: Emeryville • California • 🇺🇸 United States
Visit company websiteSalary
💰 $80 - $120 per hour
Job Level
Senior
Tech Stack
Google Cloud PlatformPMP
About the role
- 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.
- Coordinate and track inspection findings, responses, and CAPA implementation as needed.
- Partner with Quality, Clinical, Technical Operations, and Regulatory teams to ensure timely closure of commitments.
Requirements
- 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.
- PMP certification or equivalent project management training preferred.
- Experience in cell therapy and/or rare disease preferred.
- Familiarity with global inspection processes and remote inspection technologies preferred.
- Strong analytical mindset and commitment to continuous improvement.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GCPGMPinspection readinessregulatory inspectionsquality/complianceproject managementanalytical skillsCAPA implementationICH guidelinesquality system principles
Soft skills
stakeholder managementcommunication skillsorganizational skillscollaborative approachproactive approachdetail-orientedability to manage multiple projectstranslating feedback into actionexceptional project managementcommitment to continuous improvement
Certifications
PMP certificationproject management training
