Job Overview:
Leads the conduct, reporting and follow up of regional and local QA audits, ensuring compliance to applicable SOPs, Master Audit Plan, and within specified timeframes and quality standards Conducts complex, directed, and/or time sensitive QA audits Participates in global QA audits Provides suitable recommendations for audit observations; ensures auditees deliver appropriate CAPAs and follows them up through closure. Escalates, as appropriate, where resolution of audit findings is inadequate Able to support client audits and regulatory inspections Leads and/or participates in special projects Represents Audit QA on project teams and other internal forums Trains and mentors junior staff Education/Qualifications: University/college degree BA/BS (life science preferred) Knowledge, understanding, and experience applying ICH Guidelines, GCPs including applicable regulatory requirements for the conduct of clinical development programs Knowledge of the drug development process from the perspective of a contract research organization Experience Experience: 5 years CRO/Pharmaceutical experience, with global company experiences are preferred 4 years in a GXP quality role, including at least 2 years in a GCP quality audit role required