GCP Quality Assurance Consultant

Interview : Video Visa : USC, GC Description :About the jobQUALITY CONSULTANT- ContractSUMMARY:GCP Quality Assurance professional needed to support Early Access Program compliance and quality oversight for a biopharmaceutical innovator.DUTIES & RESPONSIBILITIES:* Vendor oversight* Lead compliance activities for GCP, ICH, Regulatory, SOP, and systems adherence* Lead risk assessment, root cause analysis, CAPAs and audit and regulatory filing support* Quality reviews of relevant documents and records* Other related duties, as requiredQUALIFICATIONS & REQUIREMENTS:* 10 or more years of relevant life sciences quality experience, including extensive pharmaceutical/biopharmaceutical Quality and Quality Systems compliance experience and EAP GCP expertise* Deep understanding of GxP regulations and standards* Proven experience with Early Access Programs and related quality and quality systems compliance* Excellent written, verbal, interpersonal, and teamwork communication skills, and outstanding attention to detail* Relevant bachelor's degreeLOCATION:Work can be performed remotely from home, during U.S. Eastern Time Zone business hours. Contenders should be willing to travel, if necessary.