Managing, ensuring and improving capabilities to comply with external standards and regulations
Executes against GEHC's Central Quality & Regulatory Audit program
Scheduling, preparation, execution, reporting, and follow-up activities associated with audits
Identification and communication of high-risk issues
Reporting compliance concerns and recommended improvements to business leadership
Supporting GEHC Quality Management System by defining, tracking, and maintaining metrics
Advising management in Central Quality
Communicating difficult concepts and influencing others' opinions
Requirements
Qualified Lead Auditor with active certification
Bachelors Degree
5+ years’ experience in the pharmaceutical industry; or will consider a High School Diploma and a minimum of 10 years' of progressive responsibility in the pharmaceutical industry
Minimum of 5 years’ experience driving Global programs to resolve quality compliance issues
Experience with Pharmaceutical QMS requirements and regulatory requirements including but not limited to cGMP, GDP, GPvP, GCP and GLP
Experience with Artificial Intelligence.
Benefits
medical
dental
vision
paid time off
401(k) plan with employee and company contribution opportunities
life insurance
disability insurance
accident insurance
tuition reimbursement
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Lead AuditorQuality Management SystemcGMPGDPGPvPGCPGLPArtificial Intelligence