Cmc Project Manager Jobs in North Carolina

Supports the preparation, coordination, and management of regulatory agency inspections

Develop and deliver staff training on topics related to Quality, GxP Compliance, SOPs, and Risk Management as required

5 or more years working in GMP Quality Assurance/Management with a BA in a scientific field

Perform batch record and data review/approval. Prepares GMP batches for disposition and may perform batch disposition depending on experience.

Manages internal GMP shipment procedures and approves shipments where required

Responsible for oversight of the GMP QA Vendor Qualification and Audit Program

2+ years of CMC Program Management experience in biomedical industry. Cell/gene therapy preferred.

Experience working with project management tools such as MS Project, MS Teams, MS Excel or Think-Cell; Smartsheet experience a bonus

Own the CDMO project management relationship and support tech transfer and CDMO management with LETI and ElevateBio Base Camp SMEs

1-2+ years of experience working with FDA- and/or EU-regulated Quality systems

Strong communication skills with ability to build professional relationships with external and internal stakeholders a must

SAP experience or similar ERP system is preferred