Senior Director Quality Assurance - Denovo Biopharma - (San Diego, CA)

SUMMARY The individual in this role will be accountable for establishing and managing Quality Management System (QMS) operations related to the company s products, which include but are not limited to pharmaceuticals and serum-based tests/diagnostics. Provide management with reliable solutions to quality management challenges, while ensuring overall compliance with Local, State, Federal, and International regulations and standards associated with GXP s and Quality Systems. ESSENTIAL DUTIES AND Assignments include the following: Other duties may be assigned. Serve as an experienced resource regarding GXP regulatory compliance (QA) issues for the company Establish and manage the Quality Management System (QMS) Develop and write the SOPs that are intended to support the QMS Conduct or lead the GXP audits and inspections as described in the QMS Effectively communicate audit findings and relevant trends to relevant stakeholders and corporate management