PRINCIPAL, QA

• Verifies GCP compliance to applicable Standard Operating Procedures (SOPs) and regulations
• Conducts audits of clinical sites and vendors/suppliers
• Provides full support to the Quality Management System
• Conduct external audits at clinical sites and vendor sites
• Leads process improvement activities and CAPA investigations
• Reviews clinical quality management plans and provides consultative support to clinical sites (as applicable.
• Trains junior staff on regulations and quality processes
• Supports regulatory authority inspections
• Supports business development activities, as requested
• Strong knowledge of current GCP regulations
• Experience with regulatory authority inspections
• Experience working with Quality Systems for CROs
• Experience conducting GCP clinical site audits
• Excellent written/verbal communication skills
• Proficiency in MS Office

We are equal opportunity/affirmative action employers, committed to diversity in the workplace.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.